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Informazioni sulle sperimentazioni cliniche di medicinali
ai sensi dell'art. 2 D.Lgs. n. 52/2019
Data ultimo aggiornamento: 16 dicembre 2024
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Codice Protocollo | Titolo Sperimentazione | Codice EUDRACT | Tipologia | Promotore | Unità Operativa | Principal Investigator | Codice Interno CE | Data Approvazione della Direzione | Data sottoscrizione convenzione (inizio validità) | Budget economico per paziente arruolato e completato (escluse prestazioni opzionali/condizionali e quote una tantum) | Data conclusione Sperimentazione | CV del Principal Investigator | Note |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
FIL_FOLL19 | Shortened vs standard chemotherapy combined with immunotherapy for the initial treatment of patients with high tumor burden Follicular Lymphoma. A randomized, open label, phase III study by Fondazione Italiana Linfomi | 2020-003277-22 | No Profit | Fondazione Italiana Linfomi | Ematologia | Piazza Francesco | AOP3422_CTR | DDG n. 2213 del 12/11/2024 | 12/12/2024 | 0,00 € | -- | Curriculum | -- |
GA45329 | A phase III, multicenter, double-blind, placebo-controlled, treat-through study to assess the efficacy and safety of Induction and maintenance therapy with RO7790121 in patients with moderately to Severely active ulcerative colitis | 2024- 513014-35-00 | Profit | Roche S.p.A. | Gastroenterologia | Savarino Edoardo Vincenzo | AOP3471_CTR | DDG n. 2130 del 25/10/2024 | 09/12/2024 | 18.484,85 € | -- | Curriculum | -- |
D9690C00006 | A Participant- and Investigator-blind, Randomised, Placebo-controlled Phase II Study to Evaluate Safety, Tolerability, and Mucosal Repair with AZD7798 in Patients with Active Ileal Crohnߣs Disease and an Ileostomy (CALLISTO). | 2024-514407-33 | Profit | AstraZeneca AB | Gastroenterologia | Savarino Edoardo Vincenzo | AOP3485_CTR | DDG n. 773 del 14/04/2023 | 04/12/2024 | 17.659, 95 € | -- | Curriculum | -- |
20-HMedIdeS-20 | A prospective, post-authorisation long-term follow-up trial of patients previously treated with imlifidase prior to kidney transplantation, including a non-comparative concurrent reference cohort | 2022-502727-21-00 | Profit | Hansa Biopharma AB | Chirurgia dei Trapianti di Rene e Pancreas | Furian Lucrezia | AOP3226_CTR | DDG n. 2076 del 18/10/2024 | 04/12/2024 | Gruppo trattamento con Imlifidase: 2.145,45 € Coorte di riferimento concomitante: 1.610,00 € | -- | Curriculum | -- |
JASMINE - D3463C00003 | A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Polymyositis | 2023-504022-19 | Profit | AstraZeneca | Reumatologia | Iaccarino Luca | AOP3090_CTR | DDG n. 2212 del 12/11/2024 | 04/12/2024 | 21.878,09 € | -- | Curriculum | -- |
EDG-5506-201 | A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of EDG-5506 on Safety, Biomarkers, Pharmacokinetics, and Functional Measures in Adults and Adolescents with Becker Muscular Dystrophy | 2022-500090-13 | Profit | Edgewise Therapeutics | Clinica Neurologica | Bello Luca | AOP3196_CTR | DDG n. 2086 del 23/10/2024 | 18/11/2024 | 16.203,85 € | -- | Curriculum | -- |
PHA022121-C303 | A Phase II/III, Extension Study of Orally Administered PHA-022121 for Acute Treatment of Angioedema Attacks in Patients with Hereditary Angioedema due to C1-Inhibitor Deficiency (Type I or Type II) | 2023-505766-28 | Profit | Pharvaris Netherlands BV | Allergologia | Cancian Mauro | AOP3293_CTR | DDG n. 1914 del 01/10/2024 | 11/11/2024 | 4.342,98 € | -- | Curriculum | -- |
GSK218224 | A Phase 2/3, randomized, double-blind, placebocontrolled, parallel-group study to evaluate the efficacy and safety of belimumab administered subcutaneously in adults with systemic sclerosis associated interstitial lung disease (SSc-ILD) | 2023-503219-14-01 | Profit | GlaxoSmithKline | Reumatologia | Iaccarino Luca | AOP2955 | DDG n. 1852 del 23/09/2024 | 31/10/2024 | 12.794,70 € | -- | Curriculum | -- |
SNDX-6352-0506 | A 26-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Axatilimab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | 2022-502954-15-00 | Profit | Syndax Pharmaceuticals | Pneumologia | Spagnolo Paolo | AOP3000_CTR | DDG n. 1855 del 23/09/2024 | 30/10/2024 | 16.224,74 € | -- | Curriculum | -- |
RTRX-RE021-201 | A phase 2, open-label, single-arm, cohort study to evaluate the safety, efficacy, and pharmacokinetics of sparsentan treatment in pediatric subjects with selected proteinuric glomerular diseases (EPPIK) | 2021-000621-27 | Profit | Travere Therapeutics, Inc. | Nefrologia Pediatrica | Benetti Elisa | AOP3025_CTR | DDG n. 1918 del 02/10/2024 | 30/10/2024 | 8.959,50 € | -- | Curriculum | -- |
VLX-301 | A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis | 2023-505764-11-00 | Profit | Mirum Pharmaceuticals, Inc. | Gastroenterologia | Cazzagon Nora | AOP3358_CTR | DDG n. 1972 del 07/10/2024 | 23/10/2024 | 10.046,94 € | -- | Curriculum | -- |
ALXN2220-ATTR-CM-301 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Amyloid Depleter ALXN2220 in Adult Participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) | 2023-506669-70-00 | Profit | Alexion Pharmaceuticals, Inc. | Cardiologia | Cipriani Alberto | AOP3202_CTR | DDG n. 1870 del 27/09/2024 | 23/10/2024 | 61.480,20 € | -- | Curriculum | -- |
ARGX-117-2201 | A Phase 2, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Efficacy, and Tolerability of ARGX-117 in Improving Allograft Function in Recipients of a Deceased Donor Renal Allograft at Risk for Delayed Graft Function | 2022-503091-89-00 | Profit | Argenx BV | Chirurgia dei Trapianti di Rene e Pancreas | Furian Lucrezia | AOP3079_CTR | DDG n. 1850 del 23/09/2024 | 23/10/2024 | Paziente Trapiantato: 14.103,21 € Paziente Non Trapiantato: 10.596,80 € | -- | Curriculum | -- |
1462-0004 | A randomised, double-blind, placebo-controlled, dose-finding study evaluating efficacy, safety, and tolerability of different oral doses of BI 1819479 over at least 24 weeks in patients with idiopathic pulmonary fibrosis (IPF) | 2023-508395-11-00 | Profit | Boehringer Ingelheim | Pneumologia | Balestro Elisabetta | AOP3345_CTR | DDG n. 1799 del 16/09/2024 | 21/10/2024 | 8.488,60 € | -- | Curriculum | -- |
1490-0004 | A Phase IIa/IIb, randomised, double blind, placebo-controlled, parallel-group dose-finding study to examine the efficacy and safety of BI 1839100 administered orally over a 12-week treatment period in patients with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis with clinically meaningful cough | 2023-510249-79-00 | Profit | Boehringer Ingelheim | Pneumologia | Balestro Elisabetta | AOP3344_CTR | DDG n. 1798 del 16/09/2024 | 21/10/2024 | Coorte IPF: 4.928,95 € Coorte PPF: 3.385,00 € | -- | Curriculum | -- |
PROACT PROM | PeRinatal Outcomes with ACTive versus expectant management of women with Pre-labor Rupture Of Membranes: a phase III, open-label, randomized controlled multicentric trial | 2022-002480-30 | No Profit | AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA | Clinica Ginecologica Ostetrica | Visentin Silvia | AOP2829 | DDG n. 1719 del 02/09/2024 | 21/10/2024 | 0,00 € | -- | Curriculum | -- |
APL2-C3G-314 | An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Longterm Safety and Efficacy of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis. | 2022-002833-33 | Profit | APELLIS PHARMACEUTCIALS, INC. | Nefrologia Pediatrica | Benetti Elisa | AOP3412_CTR | DDG n. 1913 del 01/10/2024 | 17/10/2024 | 8.789,02 € | -- | Curriculum | -- |
ALXN1210-IgAN-320 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN) | 2023-507851-31-00 | Profit | Alexion Pharmaceuticals, Inc. | Nefrologia 2 | Carraro Gianni | AOP3324_CTR | DDG n. 1869 del 27/09/2024 | 10/10/2024 | 20.846,00 € | -- | Curriculum | -- |
AR-DEX-22-02 | A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, and tolerability of dexpramipexole administered orally for 52 weeks in participants with severe eosinophilic asthma (EXHALE-3) | 2023-503693-20 | Profit | Areteia Therapeutics | Pneumologia | Balestro Elisabetta | AOP3280_CTR | DDG n. 1908 del 01/10/2024 | 10/10/2024 | 7.814,86 € | -- | Curriculum | -- |
ALXN1850-HPP-301 | A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN1850 (Recombinant Alkaline Phosphatase) Administered Subcutaneously in Adolescent (12 to < 18 years of age) and Adult Participants with Hypophosphatasia Who Have Not Previously Been Treated with Asfotase Alfa | 2023-505673-32-00 | Profit | Alexion Pharmaceuticals, Inc. | Clinica Medica 1 | Giannini Sandro | AOP3194_CTR | DDG n. 1871 del 27/09/2024 | 10/10/2024 | 19.285,65 € | -- | Curriculum | -- |
APG2575CG301 | A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Lisaftoclax (APG-2575) in Previously Treated Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (GLORA Study) | 2023-508005-24 | Profit | Ascentage Pharma Group Inc. | Ematologia | Visentin Andrea | AOP3237_CTR | DDG n. 1917 del 01/10/2024 | 09/10/2024 | Braccio Sperimentale: 12.146,94 € Braccio di Controllo: 8.613,58 € | -- | Curriculum | -- |
CA224-069 | A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants with Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma | 2021-000493-29 | Profit | Bristol-Myers Squibb | Clinica di Oncoematologia Pediatrica | Pillon Marta | AOP3053_CTR | DDG n. 1715 del 02/09/2024 | 30/09/2024 | Braccio A: 14.527,00 € Braccio B: 14.200,00 € | -- | Curriculum | -- |
PHA022121-C306 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults with Hereditary Angioedema | 2023-507268-37 | Profit | Pharvaris Netherlands B.V. | Allergologia | Cancian Mauro | AOP3265_CTR | DDG n. 1578 del 07/08/2024 | 28/09/2024 | 4.731,90 € | -- | Curriculum | -- |
NAL03-202 | A Randomized, Double-Blind, Placebo-Controlled, Parallel, 4-Arm Dose Ranging Study of the Safety and Efficacy of Nalbuphine Extended-Release Tablets (NAL ER) for theTreatment of Cough in Idiopathic Pulmonary Fibrosis (IPF) | 2023-505296-72-00 | Profit | Trevi Therapeutics, Inc. | Pneumologia | Spagnolo Paolo | AOP3102_CTR | DDG n. 1576 del 05/08/2024 | 26/09/2024 | 4.809,00 € | -- | Curriculum | -- |
CTQJ230A12203 | A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein(a) lowering with pelacarsen (TQJ230) on the progression of calcific aortic valve stenosis [Lp(a)FRONTIERS CAVS] | 2022-502135-19-00 | Profit | Novartis | Clinica Medica 3 | Vettor Roberto | AOP2847_CTR | DDG n. 1797 del 16/09/2024 | 26/09/2024 | 13.289,40 € | -- | Curriculum | -- |
220929 | A Phase 2, randomized, double-blind, placebocontrolled, parallel group study (TRANSFORM) to evaluate the efficacy and safety of GSK3915393 in participants with Idiopathic Pulmonary Fibrosis (IPF) | 2023- 509371-16-00 | Profit | GlaxoSmithKline Research & Development Limited | Pneumologia | Spagnolo Paolo | AOP3281_CTR | DDG n. 1716 del 02/09/2024 | 20/09/2024 | 8.358,20 € | -- | Curriculum | -- |
1305-0031 | An open-label extension trial of the long-term safety and efficacy of BI 1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) (FIBRONEERࡊ-ON) | 2023-507353-15-00 | Profit | Boehringer Ingelheim | Pneumologia | Balestro Elisabetta | AOP3214_CTR | DDG n. 1718 del 02/09/2024 | 20/09/2024 | 5.755,30 € | -- | Curriculum | -- |
54179060CLL2032 | Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients with Previously Untreated Chronic Lymphocytic Leukemia (TAILOR) | 2023-504044-34-00 | Profit | Janssen Research & Development, LLC | Ematologia | Visentin Andrea | AOP3143_CTR | DDG n. 1741 del 09/09/2024 | 20/09/2024 | Braccio 1a&b: 5.154,00 € Braccio 2a: 6.467,00 € Braccio 2b: 6.992,00 € | -- | Curriculum | -- |
NN9500-7730 | Effects of NNC0194-0499 alone and in combination with semaglutide, of semaglutide alone, and of cagrilintide alone and in combination with semaglutide on liver damage and alcohol use in people with alcohol-related liver disease | 2023-508170-28-00 | Profit | Novo Nordisk A/S | Medicina Generale | Simioni Paolo | AOP3254_CTR | DDG n. 1650 del 20/08/2024 | 11/09/2024 | 12.431,67 € | -- | Curriculum | -- |
P22-04 | A multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 2 trial to evaluate the efficacy and safety of BP1.7881 in adult patients with eosinophilic esophagitis | 2023-508949-40-00 | Profit | Bioprojet Pharma | Gastroenterologia | Savarino Edoardo Vincenzo | AOP3298_CTR | DDG n. 1430 del 15/07/2024 | 09/09/2024 | 5.221,08 € | -- | Curriculum | -- |
PASIPHY | Studio di fase II randomizzato, in doppio cieco, controllato con placebo, per la determinazione della dose per valutare lߣefficacia e la sicurezza di Pasireotide s.c. in pazienti con ipoglicemia post-bariatrica | 2023-505316-37 | Profit | RECORDATI AG | Clinica Medica 3 | Busetto Luca | AOP3267_CTR | DDG n. 1676 del 23/08/2024 | 09/09/2024 | 9.724,00 € | -- | Curriculum | -- |
DTX301-CL301 | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Adeno-Associated Virus Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Patients with Late-Onset OTC Deficiency | 2020-003384-25 | Profit | ULTRAGENYX PHARMACEUTICAL INC. | Malattie del Metabolismo | Burlina Alberto | AOP2692 | DDG n. 1256 del 25/06/2024 | 04/09/2024 |
Braccio DTX301: 48.679,61 € Braccio Placebo: 51.156,0 € | -- | Curriculum | -- |
ABX464-107 | A randomized, double-blind, multicenter phase III study to evaluate the long-term efficacy and safety of ABX464 25 mg or 50 mg once daily as a maintenance therapy in subjects with moderately to severely active ulcerative colitis. | 2022-500537-84 | Profit | Abivax | Gastroenterologia | Savarino Edoardo Vincenzo | CRT AOP2705 | DDG n. 1528 del 26/07/2024 | 30/08/2024 | Parte 1: 4.357,75 € Parte 2: 5.031,85 € | -- | Curriculum | -- |
CLIN-60190-454 | A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants with Primary Biliary Cholangitis (PBC) | 2023-505251-43-00 | Profit | IPSEN BIOSCIENCE, Inc. | Gastroenterologia | Cazzagon Nora | AOP3166_CTR | DDG n. 1616/12/08/2024 | 28/08/2024 | 20.064,52 € | -- | Curriculum | -- |
REL-1017-305 | A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of REL 1017 as Adjunctive Treatment for Major Depressive Disorder | 2023-507399-27-00 | Profit | MGGM LLC | Psichiatria 3 | Sambataro Fabio | AOP3246_CTR | DDG n. 1432 del 15/07/2024 | 27/08/2024 | 3.810,00 € | -- | Curriculum | -- |
SILYCUS-21 | Efficacy and safety of Silycus® in Cushing’s disease: a multicenter, single arm, open label, dose titration, proof of concept study (Silycus®-21) | 2020-005605-93 | Profit | ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI S.P.A. | Endocrinologia | Ceccato Filippo | AOP2621 | DDG n. 1622 del 12/08/2024 | 22/08/2024 | 4.720,55 € | -- | Curriculum | -- |
FaR-RMS | An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma | 2018-000515-24 | No Profit | University of Birmingham | Clinica di Oncoematologia Pediatrica | Bisogno Gianni | AOP2824 | DDG n. 1255 del 25/06/2024 | 13/08/2024 | 0,00 € | -- | Curriculum | -- |
ANB030-203 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis | 2023-504564-42-00 | Profit | AnaptysBio, Inc. | Reumatologia | Giollo Alessandro | AOP3203_CTR | DDG n. 1580 del 06/08/2024 | 12/08/2024 | 13.635,07 € | -- | Curriculum | -- |
CTIN816B12202 | A multicenter, randomized, double-blind, placebo-controlled, four-arm, parallel-group, dose-finding phase 2b study to investigate the safety and efficacy of TIN816 via a single intravenous infusion in the treatment of participants with sepsis-associated acute kidney injury (SA-AKI) | 2023-505903-22-00 | Profit | Novartis Farma S.p.A. | Anestesia e Rianimazione Universitaria | Navalesi Paolo | AOP3231_CTR | DDG n. 1367 del 10/07/2024 | 31/07/2024 | 10.016,85 € | -- | Curriculum | -- |
DSC-14-2357-50 | Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy, safety and tolerability of givinostat in non-ambulant patients with Duchenne Muscular Dystrophy | 2023-503521-19-00 | Profit | Italfarmaco S.p.A. | Clinica Neurologica | Pegoraro Elena | AOP3133_CTR | DDG n. 1366 del 10/07/2024 | 30/07/2024 | 6.703,00 € | -- | Curriculum | -- |
220735 | A randomized, double-blind, parallel group, multicenter study to evaluate the long-term safety of salbutamol rescue medication when administered via metered dose inhalers containing the propellant HFA-152a or reference HFA-134a | 2023-509001-76-00 | Profit | GlaxoSmithKline Research & Development Limited | Fisiopatologia Respiratoria | Vianello Andrea | AOP3239_CTR | DDG n. 1433 del 15/07/2024 | 25/07/2024 | 7.609,59 € | -- | Curriculum | -- |
A35-009 | A Phase 3 Study of Safety and Efficacy of AMX0035 in Progressive Supranuclear Palsy (ORION) | 2023-505893-14-00 | Profit | Amylyx Pharmaceuticals, Inc | Clinica Neurologica | Antonini Angelo | AOP3201_CTR | DDG n. 1431 del 15/07/2024 | 25/07/2024 | 16.321,85 € | -- | Curriculum | -- |
J3L-MC-EZEF | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults with Elevated Lipoprotein(a) who have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event | 2023-509190-23-00 | Profit | Eli Lilly and Company | Clinica Medica 1 | Zambon Alberto | AOP3261_CTR | DDG n. 1212 del 17/06/2024 | 17/07/2024 | 10.300,60 | -- | Curriculum | -- |
D4326C00004 | A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Combination Compared to Zibotentan Monotherapy as well as Zibotentan/Dapagliflozin and Zibotentan Monotherapy Compared to Placebo in Participants with Cirrhosis | 2023-506893-11 | Profit | AstraZeneca AB | Clinica Medica 5 | Piano Salvatore Silvio | AOP3228_CTR | DDG n. 1317 del 01/07/2024 | 17/07/2024 | 9.104,26 € | -- | Curriculum | -- |
BGB-11417-301 | A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia | 2023-5069-48-17-00 | Profit | BeiGene, Ltd. | Ematologia | Visentin Andrea | AOP3213_CTR | DDG n. 1313 del 01/07/2024 | 12/07/2024 | Braccio A: 18.603,00 € Braccio B: 18.888,00 € | -- | Curriculum | -- |
CXXB750A12201 | A multi-center, randomized, placebo- and active-controlled, parallel-group, 24-week proof of concept and dose-findingstudy to evaluate efficacy, safety, and tolerability of XXB750 in patients with heart failure | 2023-504678-39-00 | Profit | Novartis Farma S.p.A. | Clinica Medica 3 | Maiolino Giuseppe | AOP3204_CTR | DDG n. 1259 del 25/06/2024 | 11/07/2024 | 9.050,00 € | -- | Curriculum | -- |
283PD201 | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson’s Disease | 2021-004849-20 | Profit | Biogen Idec Research Limited | Clinica Neurologica | Antonini Angelo | AOP2703 | DDG n. 1207 del 17/06/2024 | 05/07/2024 | 20.319,00 € | -- | Curriculum | -- |
ALL2922 | Combination of Ponatinib Plus Chemotherapy As Frontline Treatment For Patients With BCR/ABL1-Like Acute Lymphoblastic Leukemia (BCR/ABL1-Like ALL) - BALLik | 2022-000633-17 | Profit | FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI | Ematologia | Lessi Federica | AOP2679 | DDG n. 1157 del 10/06/2024 | 04/07/2024 | 0,00 € | -- | Curriculum | -- |
IM011246 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (POTEYK-SLE-1) | 2022-500699-76-00 | Profit | Bristol-Myers Squibb Company | Reumatologia | Zen Margherita | AOP3084_CTR | DDG n. 1260 del 25/06/2024 | 01/07/2024 | 23.302,50 € | -- | Curriculum | -- |
D9180C00012 | Studio di fase III, multicentrico, randomizzato, in doppio cieco, a somministrazione cronica, a gruppi paralleli, controllato con placebo per valutare l'efficacia e la sicurezza di tozorakimab in partecipanti affetti da broncopneumopatia cronica ostruttiva (BPCO) sintomatica con storia di riacutizzazioni della malattia (MIRANDA) | 2023-505543-39 | Profit | ASTRAZENECA AB | Fisiopatologia Respiratoria | Guarnieri Gabriella | AOP3198 | DDG n. 1161 del 10/06/2024 | 20/06/2024 | 14.208,47 € | -- | Curriculum | -- |
D3460C00002 | Studio di fase III, multicentrico, randomizzato, a gruppi paralleli, in doppio cieco, a due bracci per valutare la sicurezza e l'efficacia di Anifrolumab rispetto al placebo in partecipanti di sesso maschile e femminile di età compresa tra 18 e 70 anni inclusi con sclerosi sistemica | 2023-505976-31 | Profit | ASTRAZENECA AB | Reumatologia | Zanatta Elisabetta | AOP3046 | DDG n. 777 del 23/04/2024 | 09/05/2024 | 14.836,63 € | -- | Curriculum | -- |
CLOSE(PS-CLL-001) | Clonal evolution in progressive CLL patients harboring subclonal TP53 aberration streated with ibrutinib first-line | 2017-001099-49 | Profit | Ospedale San Raffaele S.r.l. | Ematologia | Trentin Livio | AOP2670 | DDG n. 2108 del 29/11/2023 | 17/01/2024 | 495,00 € | -- | Curriculum | -- |
B1931036 | Studio prospettico, randomizzato, in aperto, di fase 2 per valutare la superiorità di inotuzumab ozogamicin in monoterapia rispetto ad allr3 per il trattamento di induzione della leucemia linfoblastica acuta infantile a precursori di cellule b nella prima recidiva ad alto rischio | 2022-000186-40 | Profit | PFIZER INC. | Clinica di Oncoematologia Pediatrica | Biffi Alessandra | AOP2739 | DDG n. 2251 del 21/12/2023 | 12/01/2024 | 12.074,83 € | -- | Curriculum | -- |
64407564MMY3002 | A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy | 2021-000202-22 | Profit | Janssen Cilag International NV | Ematologia | Zambello Renato | AOP2693 | DDG n. 2122 del 04/12/2023 | 18/12/2023 | Pazienti arruolati nel Braccio A: 18.654,00 € Pazienti arruolati nel Braccio B: 15.354,00 € Pazienti arruolati nel Braccio C: 18.334,00 € | -- | Curriculum | -- |
VICTORID-HF | Beneficial effects of vitamin D combined with oral iron supplementation in patients with chronic heart failure and iron deficiency (VICTORID-HF TRIAL) | 2022-004186-21 | No Profit | Dipartimento di Medicina-DIMED, università di Padova | Cardiologia | Babuin Luciano | 5822/AO/23 | DDG n. 1787 del 09/10/2023 | 05/12/2023 | 9,20 € | -- | Curriculum | -- |
CQGE031G12303B | A three-year, multi-center, double-blind, extension study to evaluate the long-term safety and efficacy of ligelizumab in patients who completed ligelizumab’s Phase III studies in food allergy | 2022-502366-25-00 | Profit | Novartis | Allergie Alimentari | Muraro Maria Antonella | AOP2952_CTR | DDG n. 2107 del 29/11/2023 | 01/12/2023 | 16.259,80 € | -- | Curriculum | -- |
A35-011 | A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX) | 2022-002348-33 | Profit | AMYLYX PHARMACEUTICALS Inc. | Clinica Neurologica | Sorarù Gianni | AOP2783 | DDG n. 1973 del 03/11/2023 | 15/11/2023 | 2.487,00 € | -- | Curriculum | -- |
VICTORID-HF | Beneficial effects of vitamin D combined with oral iron supplementation in patients with chronic heart failure and iron deficiency (VICTORID-HF TRIAL) | 2022-004186-21 | No Profit | Dipartimento di Medicina-DIMED, università di Padova | Clinica Medica 1 | Giannini Sandro | 5823/AO/23 | DDG n. 1788 del 09/10/2023 | 06/11/2023 | 9,20 € | -- | Curriculum | -- |
VICTORID-HF | Beneficial effects of vitamin D combined with oral iron supplementation in patients with chronic heart failure and iron deficiency (VICTORID-HF TRIAL) | 2022-004186-21 | No Profit | Dipartimento di Medicina-DIMED, università di Padova | Clinica Medica 3 | Vettor Roberto | 5821/AO/23 | DDG n. 1786 del 09/10/2023 | 06/11/2023 | 9,20 € | -- | Curriculum | -- |
EVENEW | Phase I single arm, dose-escalating and Phase II double blind, randomized, placebo-controlled, dose-finding Clinical Trial assessing safety and efficacy of intratracheal administration of allogeneic umbilical cord mesenchymal cells-derived Extracellular Vesicles in preventing Bronchopulmonary Dysplasia in extremely preterm newborns | 2022-500293-34-01 | Profit | EXO Biologics SA | Patologia Neonatale | Baraldi Eugenio | AOP2603_CTR | DDG n. 1789 del 09/10/2023 | 06/11/2023 | Fase I 1 adm: 7.227,13 € Fase I 3 adm: 8.176,78 € Fase II: 8.176,78 € | -- | Curriculum | -- |
VBP15-BMD-001 | A Phase II Pilot Trial of Vamorolone vs. Placebo for the Treatment of Becker Muscular Dystrophy | 2022-000844-31 | Profit | ReveraGen BioPharma Inc. | Clinica Neurologica | Pegoraro Elena | 5745/AO/23 | DDG n. 1694 del 22/09/2023 | 09/10/2023 | 2.465,48 € | -- | Curriculum | -- |
I8F-MC-GPIJ | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults with Obesity | 2022-500817-14-00 | Profit | Eli Lilly | Clinica Medica 3 | Vettor Roberto | AOP2727_CTR | DDG n. 1695 del 22/09/2023 | 03/10/2023 | 13.762,00 € | -- | Curriculum | -- |
HCL-PG05 | VEMURAFENIB + RITUXIMAB (VR) AS A CHEMOTHERAPY-FREE ALTERNATIVE TO CLADRIBINE + RITUXIMAB (CDAR) IN FRONT-LINE HAIRY CELL LEUKEMIA (HCL): A PHASE-2 RANDOMIZED MULTICENTER TRIAL | 2021-001864-12 | No Profit | DIPARTIMENTO DI MEDICINA, UNIVERSITà DI PERUGIA | Ematologia | Trentin Livio | AOP2931 | DDG n. 1297 del 07/07/2023 | 18/07/2023 | 0,00 € | -- | Curriculum | -- |
DAY101-002 | LOGGIC.FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients with Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy | 2022-001363-27 | Profit | Day One Biopharmaceuticals, Inc. | Clinica di Oncoematologia Pediatrica | Viscardi Elisabetta | 5663/AO/23 | DDG n. 1247 del 23/06/2023 | 14/07/2023 | DAY101 ARM: 4.619,80 € COG-VC ARM: 4.662,90 € SIOPe-LGG-VC ARM: 7.258,90,00 € VBL ARM: 2.560,90 € | -- | Curriculum | -- |
1305-0023 | A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) | 2022-001134-11 | Profit | BOEHRINGER-INGELHEIM ITALIA S.P.A. | Pneumologia | Balestro Elisabetta | AOP2809 | DDG n. 1248 del 23/06/2023 | 14/07/2023 | 11.136,50 € | -- | Curriculum | -- |
ADOREXT (FAB122-CT-2201) | A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | 2022-003050-32 | Profit | Ferrer Internacional S.A. | Clinica Neurologica | Sorarù Gianni | AOP2808 | DDG n. 1298 del 10/07/2023 | 11/07/2023 | 7.001,90 € | -- | Curriculum | -- |
APL2-C3G-310 | A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune- Complex Membranoproliferative Glomerulonephritis | 2020-003767-25 | Profit | APELLIS PHARMACEUTCIALS, INC. | Nefrologia Pediatrica | Benetti Elisa | 5514/AO/22 | DDG n. 1065 del 29/05/2023 | 29/06/2023 | 12.681,93 € | -- | Curriculum | -- |
19767 | Studio di fase 3, multicentrico, internazionale, randomizzato, controllato con confronto attivo, in doppio cieco, double-dummy, per gruppi paralleli a 2 bracci, per confrontare la sicurezza e l’efficacia dell’inibitore dell’FXIa orale asundexian (BAY 2433334) verso apixaban per la prevenzione di ictus o embolie sistemiche in partecipanti maschi e femmine di età pari o superiore a 18 anni affetti da fibrillazione atriale a rischio di ictus | 2022-000758-28 | Profit | BAYER AG | Malattie Trombotiche ed Emorragiche | Simioni Paolo | AOP2804 | DDG n. 1059 del 29/05/2023 | 22/06/2023 | 2.795,00 € | -- | Curriculum | -- |
IRIS | A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis | 2021-002862-42 | Profit | ASTRAZENECA AB | Reumatologia | Zen Margherita | 5698/AO/23 | DDG n. 953 del 12/05/2023 | 30/05/2023 | 21.374,40 € | -- | Curriculum | -- |
ISIS 721744-CS7 | An Open-Label, Long Term Safety and Efficacy Study of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE) | 2022-000757-93 | Profit | IONIS PHARMACEUTICALS,INC | Allergologia | Cancian Mauro | 5618/AO/22 | DDG n. 733 del 11/04/2023 | 22/05/2023 | Pazienti estensione in aperto 4 weeks: 8.510,30 € Pazienti estensione in aperto 8 weeks: 8.190,70 € Passaggio di trattamento: 9.107,30 € | -- | Curriculum | -- |
D5244C00001 | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING) | 2022-001294-31 | Profit | ASTRAZENECA AB | Gastroenterologia | Savarino Edoardo Vincenzo | Modalità transitoria DM 27/01/2023, art. 6, c. 1 | DDG n. 729 del 11/04/2023 | 18/05/2023 | 17.302,35 € | -- | Curriculum | -- |
218672/Amendment 01 | 17? -Hydroxysteroid Dehydrogenase type 13 Minimization for the treatment of NASH (HORIZON): A Double-Blind, Placebo- Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults with Pre-Cirrhotic Non-Alcoholic Steatohepatitis | 2022-002538-14 | Profit | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | Gastroenterologia | Russo Francesco Paolo | 5622/AO/22 | DDG n. 909 del 08/05/2023 | 18/05/2023 | 23.816,00 € | -- | Curriculum | -- |
1305-0014 | A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Idiopathic Pulmonary Fibrosis (IPF) | 2022-001091-34 | Profit | Boehringer Ingelheim Italia S.p.A. | Pneumologia | Balestro Elisabetta | 5638/AO/23 | DDG n. 776 del 14/04/2023 | 10/05/2023 | 11.136,50 € | -- | Curriculum | -- |
MLN0002-3024 | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | 2020-004300-34 | Profit | TAKEDA DEVELOPMENT CENTER AMERICAS INC. | Pediatria | Cananzi Mara | 5410/AO/22 | DDG n. 335 del 20/02/2023 | 27/04/2023 | 8.862,40 € | -- | Curriculum | -- |
MLN0002-3025 | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | 2020-004301-31 | Profit | TAKEDA DEVELOPMENT CENTER AMERICAS INC. | Pediatria | Cananzi Mara | 5411/AO/22 | DDG n. 334 del 20/02/2023 | 27/04/2023 | 8.657,08 € | -- | Curriculum | -- |
BCX7353-304 | A PHASE 3 STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF BEROTRALSTAT PROPHYLAXIS IN CHILDREN WITH HEREDITARY ANGIOEDEMA WHO ARE 2 TO < 12 YEARS OF AGE | 2021-005932-50 | Profit | BIOCRYST PHARMACEUTICALS INC. | Allergologia | Cancian Mauro | 5580/AO/22 | DDG n. 544 del 17/03/2023 | 20/04/2023 | 12.848,25 € | -- | Curriculum | -- |
NN9838-4608 | Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight or obesity | 2020-005435-75 | Profit | NOVO NORDISK | Medicina Generale a indirizzo Endocrino-Metabolico | Vettor Roberto | 5639/AO/23 | DDG n. 288 del 10/02/2023 | 20/04/2023 | Studio MAIN: 10.193,05 € Fase estensione: 923,90 € | -- | Curriculum | -- |
PD0055 | A DOSE-BLINDED EXTENSION STUDY TO EVALUATE THE LONG-TERM EFFICACY, SAFETY, AND TOLERABILITY OF UCB0599 IN STUDY PARTICIPANTS WITH PARKINSON'S DISEASE | 2022-500424-30-00 | Profit | UCB Biopharma SRL | Clinica Neurologica | Antonini Angelo | AOP 2694-CTR | DDG n. 673 del 31/03/2023 | 18/04/2023 | 9.345,50 € | -- | Curriculum | -- |
KONFIDENT-S | An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II | 2021-001176-42 | Profit | KalVista Pharmaceuticals Ltd. | Allergologia | Cancian Mauro | 5583/AO/23 | DDG n. 339 del 20/02/2023 | 31/03/2023 | Pazienti Rollover: 12.749,38 € Pazienti Non-Rollover: 13.159,70 € | -- | Curriculum | -- |
CLI-05993AB1-06 | STUDIO RANDOMIZZATO, IN DOPPIO CIECO, MULTINAZIONALE, MULTICENTRICO, CON CONTROLLO ATTIVO, A GRUPPI PARALLELI A 2 BRACCI, DELLA DURATA DI 26 SETTIMANE, CHE CONFRONTA CHF 5993 100/6/12,5 ?g pMDI (COMBINAZIONE FISSA DI FORMULAZIONE EXTRAFINE DI BECLOMETASONE DIPROPIONATO, FORMOTEROLO FUMARATO E GLICOPIRRONIO BROMURO) CON CHF 1535 200/6 ?g pMDI (COMBINAZIONE FISSA DI FORMULAZIONE EXTRAFINE DI BECLOMETASONE DIPROPIONATO E FORMOTEROLO FUMARATO) IN SOGGETTI CON ASMA NON CONTROLLATO CHE ASSUMONO DOSI MEDIE DI CORTICOSTEROIDI PER INALAZIONE IN COMBINAZIONE CON ß2-AGONISTI A LUNGA DURATA D’AZIONE (MiSTIC) | 2021-002391-39 | Profit | Chiesi Farmaceutici SpA | Fisiopatologia Respiratoria | Vianello Andrea | 5634/AO/23 | DDG n. 227 del 06/02/2023 | 29/03/2023 | 3.856,00 € | -- | Curriculum | -- |
ATYR1923-C-004 | A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of intravenous efzofitimod in patients with pulmonary sarcoidosis | 2022-001012-26 | Profit | aTyr Pharma, Inc. | Pneumologia | Spagnolo Paolo | 5600/AO/22 | DDG n. 422 del 24/02/2023 | 24/03/2023 | 18.475,56 € | -- | Curriculum | -- |
VTX002-201 | Studio di fase II, multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, per valutare lߣefficacia clinica e la sicurezza di VTX002 in soggetti con colite ulcerosa da moderatamente a gravemente attiva | 2021-003050-23 | Profit | Oppilan Pharma Ltd | Gastroenterologia | Zingone Fabiana | 5457/AO/22 | DDG n. 132 del 23/01/2023 | 15/03/2023 | Periodo DB, LTE, OLE 2-3, ET, 2 FUe: 19.816,50 € Periodo DB, 4 OLE , ET, 2 FU: 25.639,75 € | 29/06/2023 | Curriculum | -- |
NN7415-4616 | Open-label study investigating efficacy, safety and pharmacokinetics of concizumab prophylaxis in children below 12 years with haemophilia A or B with or without inhibitors | 2020-000504-11 | Profit | NOVO NORDISK | Malattie Trombotiche ed Emorragiche | Zanon Ezio | 5488/AO/22 | DDG n. 480 del 09/03/2023 | 15/03/2023 | 10.879,30 € | -- | Curriculum | -- |
AMUC-2023 | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC) | 2020-005232-30 | Profit | SALIX PHARMACEUTICALS, INC. | Gastroenterologia | Zingone Fabiana | 5493/AO/22 | DDG n. 131 del 23/01/2023 | 07/03/2023 | Fase DB: 6.793,46 € Fase OLE: 5.852,93 € | 12/07/2023 | Curriculum | -- |
A3907-002-Ph2 | An Open Label, Phase 2a Study to Evaluate the Effect of A3907 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Adults with Primary Sclerosing Cholangitis (PSC) | 2022-500790-14-00 | Profit | Albireo AB | Gastroenterologia | Cazzagon Nora | AOP 2695-CTR | DDG n. 336 del 20/02/2023 | 07/03/2023 | 5.377,08 € | -- | Curriculum | -- |
CTD-TCNPC-301 | A Phase 3, Double blind, Randomized, Placebo controlled, Parallel group, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of 2000 mg/kg of Trappsol® Cyclo™ (Hydroxypropyl ß cyclodextrin) and Standard of Care Compared to Placebo and Standard of Care in Patients with Niemann Pick Disease Type C1 | 2020-003136-25 | Profit | Cyclo Therapeutics, Inc. | Malattie Metaboliche ed Ereditarie | Burlina Alberto | 5361/AO/22 | DDG n. 162 del 27/01/2023 | 24/02/2023 | Pazienti > 3 anni: 82.452,14 € Pazienti < 3 anni: 76.158,19 € | -- | Curriculum | -- |
CC-93538-EE-002 | A Phase 3, Multicenter, Multinational, Open-Label Extension Study to evaluate the Long-Term Safety of CC-93538 in adult and adolescent subjects with Eosinophilic Esophagitis | 2020-004335-24 | Profit | CELGENE INTERNATIONAL SARL | Gastroenterologia | Savarino Edoardo Vincenzo | 5596/AO/22 | DDG n. 228 del 06/02/2023 | 23/02/2023 | 9.704,25 € | -- | Curriculum | -- |
HR-NBL2/SIOPEN | Studio 2 per il neuroblastoma ad alto rischio di SIOP-Europa-Neuroblastoma (SIOPEN) | 2019-001068-31 | No Profit | Istituto Gustave Roussy | Oncoematologia Pediatrica | Viscardi Elisabetta | 5239/AO/21 | DDG n. 2504 del 06/12/2022 | 23/02/2023 | 0,00 € | -- | Curriculum | -- |
230LE304 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care | 2020?005776?35 | Profit | BIOGEN IDEC RESEARCH LTD | Reumatologia | Iaccarino Luca | 5576/AO/22 | DDG n. 161 del 27/01/2023 | 23/02/2023 | 19.329,40 € | -- | Curriculum | -- |
20-HMedIdeS-19 | A controlled, open-label post-authorisation efficacy and safety study in imlifidase desensitised kidney transplant patients with positive crossmatch against a deceased donor prior to imlifidase treatment, including non-comparative registry and concurrent reference cohorts | 2021-002640-70 | Profit | Hansa Biopharma AB | Chirurgia dei Trapianti di Rene e Pancreas | Rigotti Paolo | 5531/AO/22 | DDG n. 2623 del 16/12/2022 | 20/02/2023 | 14.076,12 € | -- | Curriculum | -- |
NN7533-4470 | Studio multicentrico per valutare l’efficacia e la sicurezza di decitabinatetraidrouridina (NDec) orale in pazienti affetti da anemia falciforme | 2020-003485-39 | Profit | NOVO NORDISK | Clinica di Oncoematologia Pediatrica | Colombatti Raffaella | 5568/AO/22 | DDG n. 2740 del 28/12/2022 | 10/02/2023 | Pazienti HU non active/HU: 7.780,00 € Pazienti HU activeNDec: 8.560,00 € | -- | Curriculum | -- |
AML1819 | Studio di fase III per determinare l’impatto di gemtuzumab ozogamicin, in associazione a chemioterapia standard, sui livelli di malattia minima residua, e il ruolo di glasdegib come mantenimento post-trapianto, in pazienti adulti, di età compresa tra 18 e 60 anni, affetti da Leucemia Mieloide Acuta non precedentemente trattata, di nuova diagnosi, a rischio favorevole o intermedio | 2019-003871-20 | No Profit | Fondazione GIMEMA Onlus | Ematologia | Gurrieri Carmela | 5526/AO/22 | DDG n. 1935 del 16/09/2022 | 10/02/2023 | 0,00 € | -- | Curriculum | -- |
CA42750 | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS | 2020-005760-57 | Profit | F. HOFFMANN - LA ROCHE LTD. | Reumatologia | Iaccarino Luca | 5486/AO/22 | DDG n. 1719 del 19/08/2022 | 31/01/2023 | Trattamento in cieco: 11.500,00 € Trattamento in aperto: 6.520,00 € | -- | Curriculum | -- |
206785 | Studio di 52 settimane, randomizzato, in doppio cieco, a doppia simulazione, a gruppi paralleli, multicentrico, di non inferiorità per valutare il tasso di esacerbazione, misure aggiuntive di controllo dell’asma e la sicurezza in partecipanti adulti e adolescenti affetti da asma grave con un fenotipo eosinofilo trattati con GSK3511294 rispetto a mepolizumab o benralizumab | 2020-003612-28 | Profit | GLAXO SMITH KLINE RESEARCH & DEVELOPMENT LTD | Fisiopatologia Respiratoria | Vianello Andrea | 5482/AO/22 | DDG n. 25 del 05/01/2023 | 23/01/2023 | Braccio A Mezolipumab: 7.023,85 € Braccio B Benralizumab: 6.675,85 € | -- | Curriculum | -- |
EDOLAS | Efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) from INSTIbased three-drug regimens in HIV-1-infected adults previously naïve who achieve virological suppression | 2019-004241-32 | No Profit | Societa Italiana Malattie Infettive e Tropicali - SIMIT | Malattie Infettive | Cattelan Annamaria | 5462/AO/22 | DDG n. 1877 del 09/09/2022 | 17/01/2023 | 390,00 € | -- | Curriculum | -- |
MK-1654-007 | A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease | 2020-005996-11 | Profit | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Terapia Intensiva Neonatale | Baraldi Eugenio | 5446/AO/22 | DDG n. 2795 del 30/12/2022 | 12/01/2023 | 11.512,50 € | -- | Curriculum | -- |
PHA022121-C301 | A Phase II, Double-blind, Placebo-controlled, Randomized, Dose-ranging, Parallel Group Study to Evaluate the Safety and Efficacy of PHA-022121 Administered Orally for Prophylaxis Against Angioedema Attacks in Patients with Hereditary Angioedema due to C1-Inhibitor Deficiency (Type I or Type II) | 2021-000227-13 | Profit | Pharvaris Netherlands B.V. | Allergologia | Cancian Mauro | 5515/AO/22 | DDG n. 2505 del 06/12/2022 | 27/12/2022 | 4.340,70 € | -- | Curriculum | -- |
ATN-106 | A multicentre, prospective, open-label, uncontrolled Phase 3 study to assess the efficacy, safety and pharmacokinetics of Atenativ in patients with congenital antithrombin deficiency undergoing surgery or delivery. | 2021-004307-40 | Profit | OCTAPHARMA AG | Medicina Generale | Simioni Paolo | 5577/AO/22 | DDG n. 2399 del 18/11/2022 | 27/12/2022 | Fase PK: 6.581,69 € Fase trattamento chirurgica: 8.631,41 € Fase trattamento cesareo o parto: 7.942,40 € | -- | Curriculum | -- |
PRESERV | Randomized, multicenter, open-label study on PREvention of respiratory Sequelae of RSV bronchiolitis in preterm babies | 2018-002980-25 | No Profit | Ospedale degli Infermi di Ponderano (Biella) | Patologia Neonatale | Baraldi Eugenio | 5460/AO/22 | DDG n. 2297 del 05/11/2022 | 15/12/2022 | Importo complessivo di finanziamento previsto all'interno del bando AIFA 2016: 50.000,00 € | -- | Curriculum | -- |
IEO1360 | Studio di fase II con Camidanlumab tesirine (ADCT-301) nei pazienti anziani affetti da Linfoma di Hodgkin recidivato o refrattario dopo trattamento di prima linea o ad alto rischio di fallimento, come definito dalla persistenza di PET-positività dopo i primi due cicli di chemioterapia di prima linea. | 2020-004181-20 | No Profit | ISTITUTO EUROPEO DI ONCOLOGIA | Ematologia | Trentin Livio | 5464/AO/22 | DDG n. 2178 del 24/10/2022 | 13/12/2022 | 150,00 € | 03/01/2023 | Curriculum | -- |
ANT-007 | Studio di fase 3 multicentrico, randomizzato, in aperto, con valutazione degli endpoint in cieco volto a confrontare l’effetto di abelacimab rispetto ad apixaban sulla recidiva di tromboembolia venosa (TEV) ed eventi emorragici in pazienti con TEV associata a cancro (ASTER) | 2021-003076-14 | Profit | Anthos Therapeutics, Inc. | Medicina Generale | Simioni Paolo | 5508/AO/22 | DDG n. 2270 del 28/10/2022 | 24/11/2022 | Gruppo trattamento 1: 5.591,59 € Gruppo trattamento 2: 5.267,70 € | -- | Curriculum | -- |
ANT-008 | STUDIO DI FASE 3 MULTICENTRICO, RANDOMIZZATO, IN APERTO, CON VALUTAZIONE DEGLI ENDPOINT IN CIECO VOLTO A CONFRONTARE L’EFFETTO DI ABELACIMAB RISPETTO AD APIXABAN SULLA RECIDIVA DI TROMBOEMBOLIA VENOSA (TEV) ED EVENTI EMORRAGICI IN PAZIENTI CON TEV ASSOCIATA A CANCRO (ASTER) | 2021-003085-12 | Profit | Anthos Therapeutics, Inc. | Medicina Generale | Simioni Paolo | 5509/AO/22 | DDG n. 2057 del 07/10/2022 | 24/11/2022 | Gruppo trattamento 1: 5.591,59 € Gruppo trattamento 2: 5.267,70 € | -- | Curriculum | -- |
ISIS 721744-CS5 | A Phase 3 Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ISIS 721744 in Patients with Hereditary Angioedema (HAE) | 2021-002571-19 | Profit | IONIS PHARMACEUTICALS, INC. | Allergologia | Cancian Mauro | 5483/AO/22 | DDG n. 2179 del 24/10/2022 | 22/11/2022 | Coorte A: 7.736,85 € Coorte B: 7.501,55 € | -- | Curriculum | -- |
P-105-303 | Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, with Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation | 2021-003450-22 | Profit | AlloVir, Inc. | Clinica di Oncoematologia Pediatrica | Biffi Alessandra | 5311/AO/22 | DDG n. 2162 del 14/10/2022 | 18/11/2022 | Studio Primario: 7.153,05 € Studio Cross Over: 6.693,50 € | -- | Curriculum | -- |
ICC APL STUDY 02 | Protocollo di trattamento per bambini e adolescenti affetti da leucemia acuta promielocitica | 2017-002383-40 | No Profit | AIEOP (Associazione Italiana Ematologia Oncologia Pediatrica) | Clinica di Oncoematologia Pediatrica | Putti Maria Caterina | 5259/AO/22 | DDG n. 2180 del 24/10/2022 | 15/11/2022 | 0,00 € | -- | Curriculum | -- |
ANCHOR-2 | A randomised, double-blind, parallel group Phase III study to assess the efficacy and safety of 100 mg SC depemokimab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) – ANCHOR-2 (depemokimAb iN CHrOnic Rhinosinusitis) | 2021-005055-36 | Profit | GLAXOSMITHKLINE S.P.A. | Otorinolaringoiatria | Ottaviano Giancarlo | 5466/AO/22 | DDG n. 2038 del 04/10/2022 | 07/11/2022 | 14.987,50 € | -- | Curriculum | -- |
KVD900-301 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II | 2021-001226-21 | Profit | KalVista Pharmaceuticals Ltd | Allergologia | Cancian Mauro | 5447/AO/22 | DDG n. 1691 del 12/08/2022 | 03/11/2022 | 4.283,10 € | -- | Curriculum | -- |
ACE-536-MF-002 | Studio di fase 3, in doppio cieco, randomizzato per confrontare l’efficacia e la sicurezza di luspatercept (ACE-536) rispetto al placebo in soggetti con mielofibrosi associata a Neoplasia mieloproliferativa in terapia concomitante con un inibitore di JAK2 e che necessitano di trasfusioni di globuli rossi” | 2020-000607-36 | Profit | CELGENE CORPORATION | Ematologia | Binotto Gianni | 5181/AO/21 | DDG n. 1956 del 23/09/2022 | 24/10/2022 | Periodo trattamento principale: 10.840,00 € Periodo di estensione in cieco: 873,00 € Periodo di estensione in aperto: 1.805,00 € | -- | Curriculum | -- |
CC-93538-EE-001 | Studio di induzione e mantenimento di fase 3, multicentrico, multinazionale, randomizzato, in doppio cieco, controllato con placebo per valutare l’efficacia e la sicurezza di CC-93538 in soggetti adulti e adolescenti con esofagite eosinofila | 2020-004336-16 | Profit | CELGENE INTERNATIONAL II SRL | Gastroenterologia | Savarino Edoardo Vincenzo | 5331/AO/22 | DDG n. 1718 del 19/08/2022 | 19/10/2022 | 15.180,93 € | -- | Curriculum | -- |
Isabel | ISATUXIMAB AND AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR RELAPSED MULTIPLE MYELOMA PATIENTS (Isabel Study) | 2020-004513-13 | Profit | EMN RESEARCH ITALY IMPRESA SOCIALE S.R.L. | Ematologia | Zambello Renato | 5465/AO/22 | DDG n. 1294 del 20/06/2022 | 28/09/2022 | 800,00 € | -- | Curriculum | -- |
AIEOP-ISG OsM+ | Studio di fase II, multicentrico, randomizzato, in aperto con regime MAP +/- denosumab per il trattamento dei pazienti con osteosarcoma metastatico | 2021-002366-41 | No Profit | AIEOP (Associazione Italiana Ematologia Oncologia Pediatrica) | Clinica di Oncoematologia Pediatrica | Pierobon Marta | 5492/AO/22 | DDG n. 1448 del 12/07/2022 | 26/09/2022 | 0,00 € | -- | Curriculum | -- |
NN9535-4662 (REMODEL) | REMODEL - Renal mode of action of semaglutide in patients with type 2 diabetes and chronic kidney disease | 2020-000828-19 | Profit | NOVO NORDISK. S.P.A. | Clinica Medica 3 | Fioretto Paola | 5512/AO/22 | DDG n. 1694 del 12/08/2022 | 26/09/2022 | 5.549,20 € | -- | Curriculum | -- |
D5271C00002 | Studio di estensione a lungo termine in aperto volto a esaminare Brazikumab in partecipanti con morbo di Crohn da moderatamente a gravemente attiva (INTREPID OLE) | 2019-001866-14 | Profit | ASTRAZENECA AB | Gastroenterologia | Savarino Edoardo Vincenzo | 5380/AO/22 | DDG n. 1391 del 04/07/2022 | 15/09/2022 | 10.143,24 € | -- | Curriculum | -- |
ALL2820 | Newly Diagnosed Adult Philadelphia Chromosome Positive Acute Lumphoblastic… | 2020-006048-15 | No Profit | Fondazione GIMEMA Onlus | Ematologia | Imbergamo Silvia | 5377/AO/22 | DDG n. 1292 del 20/06/2022 | 31/08/2022 | 0,00 € | -- | Curriculum | -- |
FIL_DALYA | Uno studio in aperto di fase 2 per valutare l'attività e la sicurezza di Daratumumab in associazione con bortezomib e desametasone in pazienti con linfoma plasmablastico recidivante o refrattario (studio DALYA). | 2020-000409-94 | No Profit | FONDAZIONE ITALIANA LINFOMI ONLUS | Ematologia | Piazza Francesco | 5419/AO/22 | DDG n. 1057 del 13/05/2022 | 31/08/2022 | 0,00 € | -- | Curriculum | -- |
CNTO1959PSO4015 | A Phase 4, Interventional, Single-arm, Open-label Study Evaluating the Effect of Guselkumab on Cardiovascular Risk Surrogate Markers in Participants With Moderate to Severe Plaque Psoriasis | 2020-004061-39 | Profit | Janssen Cilag International NV | Clinica Dermatologica | Piaserico Stefano | 5273/AO/22 | DDG n. 1291 del 20/06/2022 | 08/08/2022 | 9.025,00 € | 26/10/2023 | Curriculum | -- |
A35-004 | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluatethe Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) | 2021-000250-26 | Profit | Amylyx Pharmaceuticals Inc. | Clinica Neurologica | Sorarù Gianni | 5264/AO/22 | DDG n. 1348 del 27/06/2022 | 18/07/2022 | 4.730,00 € | -- | Curriculum | -- |
CPKC412A2218 | Studio di Fase II, in aperto, a braccio singolo, per valutare la sicurezza d’impiego, l’efficacia e la farmacocinetica di midostaurina (PKC412), somministrata due volte al giorno, in associazione alla chemioterapia standard e in monoterapia postconsolidamento | 2017-004830-28 | Profit | Novartis Pharma AG | Clinica di Oncoematologia Pediatrica | Tumino Manuela | 5346/AO/22 | DDG n. 824 del 19/04/2022 | 15/06/2022 | Parte 1: 14.600,00 € Parte 2: 9.730,00 € | -- | Curriculum | -- |
AB19001 | Studio prospettico, multicentrico, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, di fase 3, per confrontare l’efficacia e la sicurezza di masitinib in combinazione con riluzolo versus placebo in combinazione con riluzolo nel trattamento di pazienti affetti da Sclerosi Laterale Amiotrofica (SLA) | 2019-001862-13 | Profit | AB SCIENCE | Clinica Neurologica | Sorarù Gianni | 5295/AO/22 | DDG n. 995 del 06/05/2022 | 15/06/2022 | 5.103,00 € | -- | Curriculum | -- |
D3258C00001 - HUDSON GI | A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) | 2021-000085-14 | Profit | AstraZeneca AB | Gastroenterologia | Savarino Edoardo Vincenzo | 5265/AO/22 | DDG n. 820 del 19/04/2022 | 15/06/2022 | 15.052,56 € | -- | Curriculum | -- |
GBT2104-131 | Studio multicentrico, randomizzato, in doppio cieco, controllato con placebo, per valutare la sicurezza e l’efficacia di inclacumab in partecipanti affetti da anemia falciforme che manifestano crisi vaso-occlusive | 2020-005286-13 | Profit | Global Blood Therapeutics INC | Clinica di Oncoematologia Pediatrica | Colombatti Raffaella | 5225/AO/21 | DDG n. 707 del 04/04/2022 | 14/06/2022 | Pazienti maggiorenni: 5.817,40 € Pazienti minorenni: 5.902,08 € | -- | Curriculum | -- |
212483/Amendment 01 | A Phase IIb, randomized, double-blind, parallel-group study to assess the efficacy, safety, tolerability, and resistance profile of GSK3640254 in combination with dolutegravir compared to dolutegravir plus lamivudine in HIV-1 infected, treatment-naïve adults | 2021-000016-28 | Profit | VIIV HEALTHCARE UK LIMITED | Malattie Infettive | Cattelan Annamaria | 5197/AO/21 | DDG n. 757 del 11/04/2022 | 14/06/2022 | 9.129,20 € | -- | Curriculum | -- |
CNTO1959CRD3001 | Protocollo di fase 2/3, randomizzato, in doppio cieco, controllato verso placebo e contro controllo attivo, a gruppi paralleli, multicentrico per valutare la sicurezza e l?efficacia di guselkumab in partecipanti con morbo di Crohn attivo da moderato a grave | 2017-002195-13 | Profit | JANSSEN-CILAG INTERNATIONAL N.V. | Gastroenterologia | Savarino Edoardo Vincenzo | 5325/AO/22 | DDG n. 818 del 19/04/2022 | 30/05/2022 | GALAXY MAIN: 10.892,50 € GALAXY LTE: 28.861,00 € | 07/12/2022 | Curriculum | -- |
3150-301-008 | Studio multicentrico, randomizzato, in doppio cieco, con doppio mascheramento, controllato con principio attivo e placebo, di fase 2b/3 senza soluzione di continuità, a gruppi paralleli della durata di 52 settimane volto a valutare l'efficacia e la sicurezza di brazikumab in partecipanti con malattia di Crohn attiva da moderata a grave. | 2018-004346-42 | Profit | ALLERGAN LIMITED | Gastroenterologia | Savarino Edoardo Vincenzo | 5263/AO/22 | DDG n. 831 del 19/04/2022 | 11/05/2022 | 12.494,36 € | -- | Curriculum | -- |
CVL-751-PD-004 | 58-WEEK OPEN-LABEL TRIAL OF TAVAPADON IN PARKINSON’S DISEASE (TEMPO-4 TRIAL) | 2019-002952-17 | Profit | Cerevel Therapeutics, LLC | Clinica Neurologica | Antonini Angelo | 5301/AO/22 | DDG n. 936 del 04/05/2022 | 09/05/2022 | Soggetti da 001: 6.994,33 € Soggetti da 003: 7.263,41 € | -- | Curriculum | -- |
BP41783 | A longitudinal, biomarker study of anti-vegf, to explore the relationship between aqueous humor composition and multimodal retinal imaging in neovascular age-related macular degeneration and diabetic macular edema. | 2020-003515-10 | Profit | F. HOFFMANN - LA ROCHE LTD. | Oculistica | Midena Edoardo | 5262/AO/22 | DDG n. 758 del 11/04/2022 | 26/04/2022 | 4.620,00 € | -- | Curriculum | -- |
20140106 | Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia | 2014-001633-84 | Profit | Amgen s.r.l. | Oncoematologia Pediatrica | Putti Maria Caterina | 5192/AO/21 | DDG n. 600 del 21/03/2022 | 21/04/2022 | Pazienti di età ?12 mesi: 13.721,00 € Pazienti di età <12 mesi: 12.540,00 € | -- | Curriculum | -- |
20200234 | A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy | 2020-003509-72 | Profit | AMGEN INC. | Reumatologia | Iaccarino Luca | 5298/AO/22 | DDG n. 538 del 14/03/2022 | 21/04/2022 | 12.062,00 € | -- | Curriculum | -- |
CRTH258AIT04 | Studio in aperto di fase IV, multicentrico, a singolo braccio di trattamento, della durata di un anno per identificare tramite imaging multimodale i biomarcatori anatomici precoci e innovativi che siano predittivi della risoluzione del fluido retinico e supportare la valutazione dell’attività di patologia in pazienti affetti da wAMD e trattati con brolucizumab. Studio IMAGINE | 2020-002452-20 | Profit | NOVARTIS FARMA | Oculistica | Midena Edoardo | 5217/AO/21 | DDG n. 421 del 01/03/2022 | 14/04/2022 | 8.000,00 € | -- | Curriculum | -- |
CQGE031G12301 | A 52 week, multi-center, randomized, double-blind placebo-controlled study to assess the clinical efficacy and safety of ligelizumab (QGE031) in decreasing the sensitivity to peanuts in patients with peanut allergy | 2020-005339-56 | Profit | NOVARTIS PHARMA AG | Allergie Alimentari | Muraro Maria Antonella | 5257/AO/21 | DDG n. 537 del 11/04/2022 | 11/04/2022 | 18.420,00 € | 20/11/2023 | Curriculum | -- |
UKM17_0023 | LBL 2018 - Protocollo internazionale per il trattamento di bambini e adolescenti con linfoma linfoblastico | 2017-001691-39 | No Profit | University Hospital Munster (UKM) | Oncoematologia Pediatrica | Pillon Marta | 5212/AO/21 | DDG n. 422 del 01/03/2022 | 11/04/2022 | 0,00 € | -- | Curriculum | -- |
SL0043 | Studio multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, per valutare l’efficacia e la sicurezza di dapirolizumab pegol in partecipanti allo studio affetti da lupus eritematoso sistemico da moderatamente a gravemente attivo | 2019-003406-27 | Profit | UCB BIOPHARMA SRL | Reumatologia | Zen Margherita | 5249/AO/21 | DDG n. 446 del 01/03/2022 | 11/04/2022 | 20.713,00 € | -- | Curriculum | -- |
CB8025-32048 | RESPONSE:A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) | 2020-004348-27 | Profit | CymaBay Therapeutics, Inc. | Gastroenterologia | Cazzagon Nora | 5220/AO/21 | DDG n. 426 del 01/03/2022 | 31/03/2022 | 3.985,76 € | 24/11/2022 | Curriculum | -- |
CA41705 | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH ISN/RPS 2003 CLASS III OR IV LUPUS NEPHRITIS | 2019-004034-42 | Profit | F. HOFFMANN - LA ROCHE LTD. | Reumatologia | Iaccarino Luca | 5123/AO/21 | DDG n. 419 del 01/03/2022 | 28/03/2022 | Parte 1: 7.050,00 € Parte 2: 8.500,00 € Parte 3: 10.150,00 € FU di sicurezza: 930,00 € | -- | Curriculum | -- |
CORT125134-452 | An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome | 2018-001616-30 | Profit | CORCEPT THERAPEUTICS | Malattie Endocrine | Scaroni Carla | 5269/AO/22 | DDG n. 436 del 17/03/2022 | 17/03/2022 | Paziente che non necessita di titolazione farmaco: 8.984,16 € Paziente che necessita di titolazione farmaco: 10.899,56 € | -- | Curriculum | -- |
BIA-91067-303 | A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson's Disease Patients, with an Open- Label Extension The EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone | 2020-005011-52 | Profit | BIAL - PORTELA & C, S.A. | Clinica Neurologica | Antonini Angelo | 5224/AO/21 | DDG n. 66 del 18/01/2022 | 02/03/2022 | Paziente che non continua trattamento open-label: 5.985,00 € Paziente che continua trattamento open-label: 10.910,00 € | -- | Curriculum | -- |
ION-682884-CS2 | A Phase 3 Global, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM) | 2019-002835-27 | Profit | ISIS PHARMACEUTICALS | Cardiologia | Cipriani Alberto | 5187/AO/21 | DDG n. 168 del 28/01/2022 | 24/02/2022 | 25.370,37 € | -- | Curriculum | -- |
MOR208C310 | A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed diffuse large B cell lymphoma (DLBCL) | 2020-002990-84 | Profit | MORPHOSYS AG | Ematologia | Piazza Francesco | 5242/AO/21 | DDG n. 223 del 10/02/2022 | 24/02/2022 | 31.448,56 € | -- | Curriculum | -- |
EX9536-4773 | Effect of Semaglutide 2.4 mg once-weekly on function and symptoms in subjects with obesityrelated heart failure with preserved ejection fraction, and type 2 diabetes | 2020-004170-22 | Profit | NOVO NORDISK | Cardiologia | Tona Francesco | 5188/AO/21 | DDG n. 2161 del 30/11/2021 | 10/02/2022 | 6.450,00 € | 03/11/2022 | Curriculum | -- |
GO42909 | PHASE III RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF MOSUNETUZUMAB IN COMBINATION WITH LENALIDOMIDE IN COMPARISON TO RITUXIMAB IN COMBINATION WITH LENALIDOMIDE IN PATIENTS WITH FOLLICULAR LYMPHOMA AFTER AT LEAST ONE LINE OF SYSTEMIC THERAPY | 2020-005239-53 | Profit | F. HOFFMANN - LA ROCHE LTD. | Ematologia | Piazza Francesco | 5253/AO/21 | DDG n. 167 del 28/01/2022 | 10/02/2022 | Braccio A: 11.210,00 € Braccio B: 8.720,00 € | -- | Curriculum | -- |
WA42294 | STUDIO DI ESTENSIONE DI FASE III IN APERTO, TESO A VALUTARE LA SICUREZZA E L'EFFICACIA A LUNGO TERMINE DI PRM-151 IN PAZIENTI AFFETTI DA FIBROSI POLMONARE IDIOPATICA (IPF) | 2020-001429-30 | Profit | F. HOFFMANN - LA ROCHE LTD. | Pneumologia | Spagnolo Paolo | 5151/AO/21 | DDG n. 108 del 24/01/2022 | 10/02/2022 | Coorte B: 12.875,00 € Coorte C: 530,00 € | 05/12/2022 | Curriculum | -- |
B7931028 | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | 2018-004175-12 | Profit | PFIZER INC. | Reumatologia | Iaccarino Luca | 5168/AO/21 | DDG n. 166 del 28/01/2022 | 10/02/2022 | 11.798,36 € | 30/06/2022 | Curriculum | -- |
GFT505B-319-1 | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid | 2019-004941-34 | Profit | GENFIT SA | Gastroenterologia | Cazzagon Nora | 5218/AO/21 | DDG n. 2387 del 24/12/2021 | 08/02/2022 | 20.412,00 € | -- | Curriculum | -- |
J1S-MS-JV02 | A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with relapsed, Recurrent, or Refractory Synovial Sarcoma | 2018-004243-23 | Profit | Eli Lilly Italia S.p.A. | Oncoematologia Pediatrica | Bisogno Gianni | 5148/AO/21 | DDG n. 2391 del 24/12/2021 | 08/02/2022 | 11.804,00 € | 02/02/2023 | Curriculum | -- |
TRS-2019-00002051 | Confronto intraclasse di sicurezza ed efficacia tra inibitori di SGLT-2 in pazienti anziani affetti da diabete tipo 2. Trial randomizzato pragmatico di fase IV multicentrico, in aperto | 2021-001167-24 | No Profit | SID - SOCIETA' ITALIANA DI DIABETOLOGIA | Malattie del Ricambio e della Nutrizione | Avogaro Angelo | 5183/AO/21 | DDG n. 2393 del 24/12/2021 | 27/01/2022 | 68.750 € complessivi per la sperimentazione | -- | Curriculum | -- |
GBT440-032 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Voxelotor (GBT440) in Pediatric Participants with Sickle Cell Disease (HOPE Kids 2) | 2017-000903-26 | Profit | Global Blood Therapeutics | Oncoematologia Pediatrica | Colombatti Raffaella | 5131/AO/21 | DDG n. 2440 del 31/12/2021 | 24/01/2022 | 11.705,00 € | 30/03/2021 | Curriculum | -- |
MO40598 | A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING THE SAFETY AND EFFICACY OF POLATUZUMAB VEDOTIN IN COMBINATION WITH RITUXIMAB PLUS GEMCITABINE PLUS OXALIPLATIN (R-GEMOX) VERSUS R-GEMOX ALONE IN PATIENTS WITH ELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA | 2018-003727-10 | Profit | F. HOFFMANN - LA ROCHE LTD. | Ematologia | Piazza Francesco | 5228/AO/21 | DDG n. 2439 del 31/12/2021 | 14/01/2022 | Braccio A: 12.360,00 € Braccio B: 10.940,00 € | -- | Curriculum | -- |
MK-1654-004 | A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full- Term Infants | 2020-002405-26 | Profit | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Terapia Intensiva Neonatale | Baraldi Eugenio | 5162/AO/21 | DDG n. 2390 del 24/12/2021 | 13/01/2022 | 5.120,00 € | -- | Curriculum | -- |
WA42293 | Studio di fase III, randomizzato, in doppio cieco, controllato verso placebo teso a valutare l'efficacia e la sicurezza di PRM-151 in pazienti affetti da fibrosi polmonare idiopatica | 2020-000791-38 | Profit | F. HOFFMANN - LA ROCHE LTD. | Pneumologia | Spagnolo Paolo | 5129/AO/21 | DDG n. 2248 del 13/12/2021 | 12/01/2022 | 10.831,00 € | 30/11/2022 | Curriculum | -- |
EFC16035 | A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS) | 2020-000645-14 | Profit | GENZYME CORPORATION | Neurologia | Puthenparampil Marco | 5130/AO/21 | DDG n. 2249 del 13/12/2021 | 11/01/2022 | 31.850,00 € | -- | Curriculum | -- |
BN42358 | A phase IIb, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of intravenous prasinezumab in participants with early Parkinson's disease | 2020-004997-23 | Profit | F. HOFFMANN - LA ROCHE LTD. | Clinica Neurologica | Antonini Angelo | 5112/AO/21 | DDG n. 2280 del 13/12/2021 | 05/01/2022 | 24.340,00 € | -- | Curriculum | -- |
KVD824-201 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of Three Dose Levels of KVD824, an Oral Plasma Kallikrein Inhibitor, for Long-Term Prophylactic Treatment of Hereditary Angioedema Type I or II | 2021-000136-59 | Profit | KalVista Pharmaceuticals Ltd. | U.O.S.D. Allergologia | Cancian Mauro | 5171/AO/21 | DDG n. 2116 del 24/11/2021 | 22/12/2021 | 3.666,00 € | 27/01/2023 | Curriculum | -- |
GN41851 | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | 2019-004857-10 | Profit | F. HOFFMANN - LA ROCHE LTD. | Clinica Neurologica | Puthenparampil Marco | 5152/AO/21 | DDG n. 2113 del 24/11/2021 | 21/12/2021 | Double-Blind Treatment (DBT): 10.660,00 € Double-Blind Treatment after Study Treatment Discontinuation (STD): 7.570,00 € Open Label Extension (OLE): 5.500,00 € | -- | Curriculum | -- |
FIL_Dara-GDP | Studio di fase II, in aperto, multicentrico con Daratumumab in combinazione con gemcitabina, desametasone e cisplatino (D-GDP) per il trattamento di pazienti con diagnosi di linfoma a cellule T periferico CD38 positivo ricaduto/refrattario di tipo non ulteriormente specificato (PTCL-NOS), angioimmunoblastico (AITL) e con fenotipo Tfollicular helper (TFH) | 2018-002644-91 | No Profit | FONDAZIONE ITALIANA LINFOMI ONLUS | Ematologia | Piazza Francesco | 5164/AO/21 | DDG n. 2110 del 24/11/2021 | 21/12/2021 | 0,00 € | 20/03/2023 | Curriculum | -- |
4202-HEM-301 | An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral FT-4202, a Pyruvate Kinase Activator in Patients with Sickle Cell Disease (PRAISE) | 2020-003884-25 | Profit | FORMA THERAPEUTICS INC | Clinica di Oncoematologia Pediatrica | Colombatti Raffaella | 5116/AO/21 | DDG n. 1979 del 04/11/2021 | 06/12/2021 | 11.418,27 € | -- | Curriculum | -- |
cHL-PG01 | A phase-II academic trial testing, in two parallel non-randomized cohorts, the combination of ruxolitinib (JAK1/2 inhibitor) with brentuximab or nivolumab in relapsed or refractory classical Hodgkin lymphoma (cHL) | 2019-003084-21 | No Profit | UNIVERSITA' DEGLI STUDI DI PERUGIA | Ematologia | Trentin Livio | 5111/AO/21 | DDG n. 1628 del 08/09/2021 | 06/12/2021 | 0,00 € | -- | Curriculum | -- |
NBI-74788-CAH3003 | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment | 2019-004873-17 | Profit | Neurocrine Biosciences, Inc. | Endocrinologia | Scaroni Carla | 5085/AO/21 | DDG n. 1879 del 21/10/2021 | 06/12/2021 | 20.195,00 € | -- | Curriculum | -- |
VERDICT | VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target | 2019-002485-12 | Profit | Alimentiv Inc. | Gastroenterologia | Savarino Edoardo Vincenzo | 5066/AO/21 | DDG n. 1929 del 28/10/2021 | 02/12/2021 | 3.406,00 € | -- | Curriculum | -- |
CVL-751-PD-003 | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) | 2019-002951-40 | Profit | Cerevel Therapeutics, LLC | Clinica Neurologica | Antonini Angelo | 5113/AO/21 | DDG n. 1794 del 05/10/2021 | 19/11/2021 | 8.296,69 € | -- | Curriculum | -- |
DAISY | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir in Infants and Children (?28 Days to ?5 Years of Age) and Subsequently in Neonates (<28 Days of Age), Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV) | 2020-002023-11 | Profit | JANSSEN-CILAG INTERNATIONAL N.V. | Accettazione e Pronto Soccorso Pediatrico | Bressan Silvia | 5086/AO/21 | DDG n. 1793 del 05/10/2021 | 12/11/2021 | Paziente Ospedaliero (Ricoverato): 11.338,00 € Paziente Dopo le Dimissioni: 5.089,00 € | -- | Curriculum | -- |
NN9500-4656 | Efficacy and safety investigation of NNC0194-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial | 2020-003566-39 | Profit | NOVO NORDISK | Medicina Generale a indirizzo Endocrino-Metabolico | Vettor Roberto | 5117/AO/21 | DDG n. 1840 del 11/10/2021 | 12/11/2021 | 12.210,00 € | -- | Curriculum | -- |
KS301P104 | A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared with Intravitreal Aflibercept in Participants with Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME) | 2020-001062-11 | Profit | Kodiak Sciences Inc. | Clinica Oculistica | Midena Edoardo | 5109/AO/21 | DDG n. 1886 del 21/10/2021 | 03/11/2021 | 31.186,85 € | -- | Curriculum | -- |
A4250-012 | A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT) | 2020-004011-28 | Profit | Albireo AB | Clinica Pediatrica | Cananzi Mara | 5070/AO/21 | DDG n. 1550 del 20/08/2021 | 26/10/2021 | 8.549,11 € | -- | Curriculum | -- |
TBRU-dS-RAC-PII | A Phase II, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermo-epidermal skin substitute (EHSG-KF) for the treatment of full-thickness skin defects in adults and children in comparison to autologous split-thickness skin grafts (STSG) | 2017-002462-41 | Profit | UNIVERSITA' DI ZURIGO | Grandi Ustionati | Azzena Bruno | 5096/AO/21 | DDG n. 1253 del 07/07/2021 | 06/10/2021 | 5.370,00 € | -- | Curriculum | -- |
TBRU-dS-BC-PIIb | Studio multicentrico, prospettico, randomizzato e controllato intrapaziente, di fase IIb, sulla sicurezza ed efficacia di un sostituto cutaneo dermoepidermico bioingegnerizzato (EHSGKF) per il trattamento di ustioni a spessore parziale o a spessore completo nei bambini, in confronto con l'innesto di cute a spessore parziale autologa. | 2017-002461-21 | Profit | University Hospital of Zurich | Grandi Ustionati | Azzena Bruno | 5097/AO/21 | DDG n. 1254 del 07/07/2021 | 06/10/2021 | 5.370,00 € | -- | Curriculum | -- |
TBRU-dS-BA-PIIb | Studio multicentrico, prospettico, randomizzato e controllato intrapaziente, di fase IIb, sulla sicurezza ed efficacia di un sostituto cutaneo dermoepidermico bioingegnerizzato (EHSGKF) per il trattamento di ustioni a spessore parziale o a spessore completo negli adulti e negli adolescenti, in confronto con l'innesto di cute a spessore parziale autologa. | 2017-002460-41 | Profit | University Hospital of Zurich | Grandi Ustionati | Azzena Bruno | 5098/AO/21 | DDG n. 1255 del 07/07/2021 | 06/10/2021 | 5.370,00 € | -- | Curriculum | -- |
PD0053 | A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's Disease | 2020-003265-19 | Profit | UCB BIOPHARMA SPRL | Clinica Neurologica | Antonini Angelo | 5047/AO/21 | DDG n. 1583 del 30/08/2021 | 04/10/2021 | 15.713,00 € | -- | Curriculum | -- |
CORT125134-456 | Glucocorticoid Receptor Antagonism in the Treatment of Hypercortisolism in Patients with Cortisol-Secreting Adrenal Adenomas or Hyperplasia (GRADIENT): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Relacorilant | 2019-004956-12 | Profit | CORCEPT THERAPEUTICS | Endocrinologia | Scaroni Carla | 5069/AO/21 | DDG n. 1653 del 13/09/2021 | 04/10/2021 | 4.864,86 € | -- | Curriculum | -- |
BUL-3/EER | Double-blind, randomized phase III trial in adult and adolescent patients with eosinophilic esophagitis to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining clinico-histological remission | 2017-003516-39 | Profit | DR. FALK PHARMA GMBH | Gastroenterologia | Savarino Edoardo Vincenzo | 5114/AO/21 | DDG n. 1451 del 30/07/2021 | 04/10/2021 | 2.990,00 € | -- | Curriculum | -- |
212358 | Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis | 2019-003158-10 | Profit | GLAXO SMITH KLINE RESEARCH & DEVELOPMENT LTD | Gastroenterologia | Cazzagon Nora | 5078/AO/21 | DDG n. 1407 del 26/07/2021 | 23/09/2021 | 8.180,00 € | -- | Curriculum | -- |
LOXO-TRK-15003 | A Phase 1/2 Study of the Oral TRK Inhibitor LOXO-101 in Pediatric Patients with Advanced Solid or Primary Central Nervous System Tumors | 2016-003498-16 | Profit | Loxo Oncology Inc | Clinica di Oncoematologia Pediatrica | Bisogno Gianni | 4290/AO/17 | DDG n. 1582 del 30/08/2021 | 20/09/2021 | 7.777,19 € | -- | Curriculum | -- |
CLJN452D12201C | A randomized,duble -blind, parallel-group, multicenter study to assess efficacy ,safety. and torelability of oral tropifexor (LJN452) & licogliflozin (LIK066) combination therapy, compered to cech monotherapy, for teatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fribrosis (ELIVATE) | 2019-002324-32 | Profit | NOVARTIS FARMA | Clinica Medica 5 | Angeli Paolo | 5063/AO/21 | DDG n. 1101 del 15/06/2021 | 07/09/2021 | 6.160,00 € | 28/07/2022 | Curriculum | -- |
CVL-751-PD-001 | A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, 27-WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) | 2019-002949-38 | Profit | Cerevel Therapeutics, LLC | Clinica Neurologica | Antonini Angelo | 5040/AO/21 | DDG n. 1252 del 07/07/2021 | 01/09/2021 | 9.280,51 € | -- | Curriculum | -- |
CSEG101A2401B | Studio in aperto, multicentrico, di Fase IV, rollover, in pazienti con anemia falciforme che hanno completato uno studio precedente con crizanlizumab sponsorizzato da Novartis | 2020-004225-22 | Profit | NOVARTIS PHARMA AG | Clinica di Oncoematologia Pediatrica | Colombatti Raffaella | 5099/AO/21 | DDG n. 1450 del 30/07/2021 | 23/08/2021 | 23.850,00 € | -- | Curriculum | -- |
SP-PP18 | Personalized Versus Standardized Parenteral Nutrition for Preterm Infants With a Birth Weight Greater Than 1250 Grams: a Multicenter Randomized Phase IV Clinical Trial | 2018-004946-41 | No Profit | AOU Ospedali Riuniti Ancona | Patologia Neonatale | Baraldi Eugenio | 5064/AO/21 | DDG n. 1059 del 09/06/2021 | 23/08/2021 | 0,00 € | -- | Curriculum | -- |
THEIA | A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants with New-Onset or Relapsing Giant Cell Arteritis | 2020-000622-26 | Profit | JANSSEN-CILAG INTERNATIONAL N.V. | Reumatologia | Schiavon Franco | 5083/AO/21 | DDG n. 1156 del 22/06/2021 | 23/08/2021 | 8.889,00 € | -- | Curriculum | -- |
AIEOP-BFM ALL 2017 | Studio cooperativo internazionale per il trattamento di bambini ed adolescenti affetti da Leucemia Linfoblastica Acuta | 2016-001935-12 | No Profit | A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA | Clinica di Oncoematologia Pediatrica | Putti Maria Caterina | 5061/AO/21 | DDG n. 1061 del 09/06/2021 | 22/07/2021 | 0,00 € | -- | Curriculum | -- |
V1605-201 | Studio di fase 2 teso a valutare la sensibilità, la specificità e la sicurezza di DBV1605, un atopy patch test pronto all'uso per la diagnosi di allergia al latte vaccino non-immunoglobulina E mediata nei bambini | 2019-004523-21 | Profit | DBV Technologies S.A. | U.O.S.D. Allergie Alimentari | Muraro Maria Antonella | 5084/AO/21 | DDG n. 1155 del 22/06/2021 | 19/07/2021 | 3.823,00 € | -- | Curriculum | -- |
GIASONE (FAAI2.1 0 .201 8) | Studio Giasone (The Jason study) Prevenzione secondaria con Sulodexide (VESSEL®) nei pazienti anziani dopo un primo episodio di tromboembolismo venoso (TEV) Codice Protocollo: | 2019-000570-33 | No Profit | FONDAZIONE ARIANNA ANTICOAGULAZIONE | Clinica Medica 1 | Sartori Maria Teresa | 5075/AO/21 | DDG n. 1103 del 15/06/2021 | 16/07/2021 | 0,00 € | -- | Curriculum | -- |
MK-3475-051 | Studio di fase I/II su pembrolizumab (MK-3475) in bambini affetti da melanoma avanzato o da tumore solido o linfoma avanzato, recidivante o refrattario, PD-L1 positivo (KEYNOTE- 051). | 2014-002958-38 | Profit | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Clinica di Oncoematologia Pediatrica | Pillon Marta | 5035/AO/21 | DDG n. 1102 del 15/06/2021 | 14/07/2021 | Q3W dosing: 15.711,00 €2nd course phase: 14.194,00 €rrCHL: 18.121,50 € | 12/05/2023 | Curriculum | -- |
J1S-MC-JV01 e J1S-MC-JAAA | A Randomized, Open-Label Phase 2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor | 2018-004242-42 | Profit | ELI LILLY AND COMPANY | Clinica di Oncoematologia Pediatrica | Bisogno Gianni | 4969/AO/20 | DDG n. 1060 del 09/06/2021 | 09/07/2021 | 16.391,00 € | -- | Curriculum | -- |
CAIN457Q12301 | A two-year, phase III randomized, double-blind, parallelgroup, placebo-controlled trial to evaluate the safety, efficacy, and tolerability of 300 mg s.c. secukinumab versus placebo, in combination with SoC therapy, in patients with active lupus nephritis | 2019-003211-57 | Profit | NOVARTIS PHARMA AG | Reumatologia | Iaccarino Luca | 5038/AO/21 | DDG n. 856 del 10/05/2021 | 09/07/2021 | 13.650,00 € | -- | Curriculum | -- |
APH-19 | Phase III, single-arm, open-label, international, multi-centre study to evaluate the efficacy and safety of lomitapide in paediatric patients with Homozygous Familial Hypercholesterolaemia (HoFH) on stable lipid-lowering therapy | 2019-002278-30 | Profit | Amryt Pharmaceuticals DAC | Clinica Medica 1 | Zambon Alberto | 5065/AO/21 | DDG n. 855 del 10/05/2021 | 21/06/2021 | 16.018,00 € | -- | Curriculum | -- |
TV48125-CNS-30082 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Chronic Migraine in Pediatric Patients 6 to 17 Years of Age | 2019-002053-33 | Profit | TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. | Clinica Pediatrica | Toldo Irene | 5042/AO/21 | DDG n. 614 del 09/04/2021 | 16/06/2021 | 3.095,00 € | -- | Curriculum | -- |
TV48125-CNS-30083 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age | 2019-002055-42 | Profit | TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. | Clinica Pediatrica | Toldo Irene | 5043/AO/21 | DDG n. 749 del 27/04/2021 | 16/06/2021 | 3.095,00 € | -- | Curriculum | -- |
TV48125-CNS-30084 | A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age | 2019-002056-16 | Profit | TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. | Clinica Pediatrica | Toldo Irene | 5044/AO/21 | DDG n. 750 del 27/04/2021 | 16/06/2021 | 5.364,00 € | -- | Curriculum | -- |
CNTO1959UCO3001 | Studio multicentrico di fase IIb/III randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare l’efficacia e la sicurezza di guselkumab in soggetti con colite ulcerosa ad attività moderata-severa | 2018-004002-25 | Profit | JANSSEN CILAG INTERNATIONAL NV | Gastroenterologia | Savarino Edoardo Vincenzo | 4979/AO/20 | DDG n. 858 del 10/05/2021 | 10/06/2021 | 20.022,00 € | -- | Curriculum | -- |
69TER/2020 | Trial Clinico Randomizzato con Nafamostat: un potente inibitore di TMPRSS2 per il trattamento dei pazienti affetti da Covid-19 | 2020-002570-27 | No Profit | Dipartimento di Medicina - DIMED - Universita degli Studi di Padova | Clinica Medica 3 | Fioretto Paola | COVID 04 | DDG n. 868 del 14/05/2021 | 28/05/2021 | 53,05 € | -- | Curriculum | -- |
69TER/2020 | Trial Clinico Randomizzato con Nafamostat: un potente inibitore di TMPRSS2 per il trattamento dei pazienti affetti da Covid-19 | 2020-002570-27 | No Profit | Dipartimento di Medicina - DIMED - Universita degli Studi di Padova | Fisiopatologia Respiratoria | Vianello Andrea | COVID 04 | DDG n. 868 del 14/05/2021 | 28/05/2021 | 53,05 € | -- | Curriculum | -- |
69TER/2020 | Trial Clinico Randomizzato con Nafamostat: un potente inibitore di TMPRSS2 per il trattamento dei pazienti affetti da Covid-19 | 2020-002570-27 | No Profit | Dipartimento di Medicina - DIMED - Universita degli Studi di Padova | Malattie Infettive | Cattelan Annamaria | COVID 04 | DDG n. 868 del 14/05/2021 | 28/05/2021 | 53,05 € | -- | Curriculum | -- |
TD-1473 (0164) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) | 2018-002135-19 | Profit | THERAVANCE | Gastroenterologia | D'Inca' Renata | 4949/AO/20 | DDG n. 822 del 06/05/2021 | 21/05/2021 | 14.410,00 € | 01/09/2021 | Curriculum | -- |
A4250-011 | A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) | 2019-003807-37 | Profit | Albireo AB | Clinica Pediatrica | Cananzi Mara | 5034/AO/21 | DDG n. 612 del 09/04/2021 | 14/05/2021 | 8.487,58 € | -- | Curriculum | -- |
RDG-1/PBC (RHUBY) | Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis | 2020-001961-34 | Profit | DR. FALK PHARMA GMBH | Gastroenterologia | Cazzagon Nora | 5041/AO/21 | DDG n. 611 del 09/04/2021 | 14/05/2021 | 4.000,00 € | 08/03/2023 | Curriculum | -- |
LP0160-1396 | A phase 3, randomised, double-blind, multi-centre trial to evaluate the efficacy, safety, and tolerability of brodalumab treatment compared to placebo (blinded) and ustekinumab (open-label) in adolescent subjects (12–17 years of age) with moderate-tosevere plaque psoriasis | 2019-001868-30 | Profit | LEO PHARMA A/S | Clinica Dermatologica | Belloni Fortina Anna | 5028/AO/21 | DDG n. 616 del 09/04/2021 | 12/05/2021 | 13.140,00 € | -- | Curriculum | -- |
ISEE2008 | A Phase 3 Multicenter, Randomized, Double Masked, Sham-Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura™ (Complement C5 Inhibitor) in Patients with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration | 2020-000676-38 | Profit | IVERIC bio, Inc. | Clinica Oculistica | Midena Edoardo | 4984/A0/20 | DDG n. 437 del 25/03/2021 | 14/04/2021 | 30.548,70 € | -- | Curriculum | -- |
PCYC-1145-LT | Extended treatment protocol for subjects continuing to benefit from ibrutinib after completion of ibrutinib clinical trials | 2016-004356-30 | Profit | PHARMACYCLICS INC. | Ematologia | Trentin Livio | 5029/AO/21 | DDG n. 436 del 25/03/2021 | 14/04/2021 | 3.048,00 € | -- | Curriculum | -- |
BIA-91067-404 | Studio clinico randomizzato in doppio cieco, controllato con placebo per valutare l’effetto di opicapone 50 mg in pazienti affetti da malattia di Parkinson con fluttuazioni motorie di fine dose e dolore associato. | 2020-001175-32 | Profit | BIAL - PORTELA & C, S.A. | Clinica Neurologica | Antonini Angelo | 4987/A0/20 | DDG n. 104 del 25/01/2021 | 02/04/2021 | 4.500,00 € | -- | Curriculum | -- |
PN-943-03 | Studio di Fase 2, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, multicentrico per valutare la sicurezza e l’efficacia di PN-943 orale in soggetti con colite ulcerosa attiva da moderata a grave | 2019-004469-41 | Profit | Protagonist Therapeutics, Inc | Gastroenterologia | D'Inca' Renata Dal 01/07/2021 Fabiana Zingone | 4970/AO/20 | DDG n. 199 del 04/02/2021 | 02/04/2021 | 6.971,00 € | -- | Curriculum | -- |
IRL790C005 | A randomized, double-blind, placebo-controlled phase IIB study evaluating the efficacy of mesdopetam on DAILY on-time without troublesome dyskinesia in patients with Parkinson's disease | 2020-002010-41 | Profit | Integrative Research Laboratories Sweden AB | Clinica Neurologica | Antonini Angelo | 5003/AO/21 | DDG n. 196 del 04/02/2021 | 01/04/2021 | 5.016,13 € | 14/11/2022 | Curriculum | -- |
EMN20 | Carfilzomib - Lenalidomide - Dexamethasone (KRd) versus Lenalidomide - Dexamethasone (Rd) in newly diagnosed myeloma patients not eligible for autologous stem cell transplantation: a randomized phase III trial | 2018-002068-15 | No Profit | FONDAZIONE NEOPLASIE SANGUE ONLUS | Ematologia | Zambello Renato | 4965/AO/20 | DDG n. 39 del 14/01/2021 | 01/04/2021 | 535,20 € | -- | Curriculum | -- |
FGCL-3019-095 | Zephyrus II: Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo sull’efficacia e sulla sicurezza di pamrevlumab in soggetti affetti da fibrosi polmonare idiopatica (IPF) | 2020-000697-22 | Profit | FIBROGEN | Pneumologia | Balestro Elisabetta | 4999/AO/21 | DDG n. 194 del 04/02/2021 | 01/04/2021 | 10.200,00 € | -- | Curriculum | -- |
CORT125134-455 | Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant | 2018-003096-35 | Profit | CORCEPT THERAPEUTICS | Endocrinologia | Scaroni Carla | 4971/AO/20 | DDG n. 200 del 04/02/2021 | 23/02/2021 | 7.227,29 € | -- | Curriculum | -- |
1305-0013 | A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 18 mg taken orally b.i.d. | 2019-004167-45 | Profit | BOEHRINGER ING. | Pneumologia | Balestro Elisabetta | 4929/AO/20 | DDG n. 101 del 22/01/2021 | 19/02/2021 | 5.650,00 € | 28/01/2022 | Curriculum | -- |
1199-0337 | A double blind, randomised, placebo-controlled trial to evaluate the dose-exposure and safety of nintedanib per os on top of standard of care for 24 weeks, followed by open label treatment with nintedanib of variable duration, in children and adolescents (6 to 17 year-old) with clinically significant fibrosing Interstitial Lung Disease | 2018-004530-14 | Profit | BOEHRINGER ING. | Pneumologia e Allergologia Pediatrica | Zanconato Stefania | 4975/AO/20 | DDG n. 192 del 04/02/2021 | 19/02/2021 | 11.590,00 € | -- | Curriculum | -- |
HS-18-633 | Studio multicentrico, controllato con placebo, in doppio cieco, randomizzato, di fase III con lo scopo di valutare l’efficacia e la sicurezza del deposito sottocutaneo di octreotide (CAM2029) in pazienti affetti da acromegalia | 2019-001191-11 | Profit | Camurus AB | Clinica Medica 3 | Maffei Pietro | 4870/AO/20 | DDG n. 1327 del 02/10/2020 | 12/02/2021 | 9.320,00 € | -- | Curriculum | -- |
HS-19-647 | Studio multicentrico, in aperto, a braccio singolo, di fase III con lo scopo di valutare la sicurezza a lungo termine del deposito sottocutaneo di octreotide (CAM2029) in pazienti affetti da acromegalia | 2019-002190-66 | Profit | Camurus AB | Clinica Medica 3 | Maffei Pietro | 4883/AO/20 | DDG n. 1326 del 02/10/2020 | 12/02/2021 | Nuovi pazienti: 13.070,00 € Pazienti roll-over studio HS-18-633: 4.630,00 € | -- | Curriculum | -- |
CHS1221 (CESSA) | A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum | 2019-003596-19 | Profit | Cristcot HCA LLC. | Gastroenterologia | Savarino Edoardo Vincenzo | 4985/AO/20 | DDG n. 42 del 14/01/2021 | 09/02/2021 | 4.588,00 € | -- | Curriculum | -- |
Ig-FAT | Efficacy and safety of adjunctive IgM-enriched immunoglobulin therapy with a personalized dose based on serum IgM-titers vs. standard dose in patients with septic shock. A multicenter, interventional, randomized, single-bilinded, two arms, adaptive design. | 2018-001613-33 | No Profit | AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA | Anestesia e Rianimazione | Feltracco Paolo | 4905/AO/20 | DDG n. 40 del 14/01/2021 | 03/02/2021 | 0,00 € | -- | Curriculum | -- |
IM011073 | A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis | 2018-004142-42 | Profit | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | Reumatologia | Iaccarino Luca | 4926/AO/20 | DDG n. 1731 del 04/12/2020 | 01/02/2021 | Parte A: 2.269,00 € Parte B: 14.236,73,00 € | -- | Curriculum | -- |
GS-US-540-5823 | A Phase 2/3 Single-Arm, Open-LabelStudy to Evaluate the Safety, Tolerability,Pharmacokinetics, andEfficacy of Remdesivir (GS-5734™) in Participants from Birth to <18 Years of Agewith COVID-19 | 2020-001803-17 | Profit | GILEAD SCIENCE INC. | Clinica Pediatrica | Giaquinto Carlo | COVID 01 | DDG n. 1842 del 22/12/2020 | 15/01/2021 | 9.914,00 € | -- | Curriculum | -- |
AC-065A310 | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged ?2 to <18 years with Pulmonary Arterial Hypertension | 2019-002817-21 | Profit | ACTELION PHARMACEUTICALS LTD. | Cardiologia Pediatrica | Castaldi Biagio | 4968/AO/20 | DDG n. 1730 del 04/12/2020 | 28/12/2020 | 13.327,00 € | -- | Curriculum | -- |
CYC-202 | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | 2018-003349-41 | Profit | Sublimity Therapeutics (Hold Co) Ltd. | Gastroenterologia | Savarino Edoardo Vincenzo | 4921/AO/20 | DDG n. 1333 del 02/10/2020 | 18/12/2020 | 8.483,00 € | -- | Curriculum | -- |
67864238PACRD2001 | Uno studio di tipo platform di fase 2, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l’efficacia e la sicurezza di trattamenti nei partecipanti affetti da malattia di Crohn attiva di grado da moderato a severo: Intervento JNJ-67864238 | 2019-003335-37 | Profit | JANSSEN-CILAG INTERNATIONAL N.V. | Gastroenterologia | Savarino Edoardo Vincenzo | 4874/AO/20 | DDG n. 1637 del 20/11/2020 | 10/12/2020 | 5.174,00 € | 05/11/2021 | Curriculum | -- |
B7541007 | A phase 2b, Multicenter, Randomized, double-blind, placebo-controlled dose-ranging study toevaluate the efficacy, safety, and pharmacokinetics of PF-06480605 in adult participants withmoderate to severe ulcerative colitis. | 2019-002698-74 | Profit | PFIZER INC. | Gastroenterologia | Savarino Edoardo Vincenzo | 4914/AO/20 | DDG n. 1577 del 13/11/2020 | 01/12/2020 | 8.213,96 € | 09/05/2023 | Curriculum | -- |
E7389-G000-213 prot. v. 04 | Studio dei fase 1/2 a braccio singolo per valutare la sicurezza e l'efficacia di eribulina mesilato in combinazione con irinotecan in bambini con tumori solidi o refrattari | 2016-003352-67 | Profit | EISAI LTD UK | Clinica di Oncoematologia Pediatrica | Bisogno Gianni | 4951/AO/20 | DDG n. 1575 del 13/11/2020 | 26/11/2020 | 20.276,10 € | 17/08/2021 | Curriculum | -- |
1245-0137 | Studio clinico multicentrico internazionale randomizzato in doppio cieco controllato con placebo per valutare l’effetto di empagliflozin, una volta al giorno, sugli esiti cardio-renali in pazienti con insufficienza renale cronica | 2017-002971-24 | Profit | BOEHRINGER INGELHEIM INTERNATIONAL GMBH | Clinica Medica 3 | Fioretto Paola | 4927/AO/20 | DDG n. 1574 del 13/11/2020 | 26/11/2020 | 1.750,00 € | -- | Curriculum | -- |
NGAM-12 | Double-blind, randomized, placebo-controlled, prospective phase III study evaluating efficacy and safety of panzyga in primary infection prophylaxis in patients with chronic lymphocytic leukemia (“PRO-SID” study) | 2019-004375-40 | Profit | Octapharma Pharmazeutika Produktionsges. m.b.H. | Ematologia | Trentin Livio | 4955/AO/20 | DDG n. 1573 del 13/11/2020 | 26/11/2020 | 9.162,00 € | -- | Curriculum | -- |
IM011024 | A Phase 2 Randomized, Double-Blind, Placebo Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis | 2018-004694-27 | Profit | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | Gastroenterologia | Savarino Edoardo Vincenzo | 4866/AO/20 | DDG n. 1486 del 23/10/2020 | 25/11/2020 | 10.696,00 € | 23/02/2022 | Curriculum | -- |
CCFZ533A2202 | A 12-month, open-label, multicenter, randomized safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) study of two regimens of anti-CD40 monoclonal antibody, CFZ533 vs. standard of care control, in adult de novo liver transplant recipients with a 12-month additional follow-up. | 2018-001836-24 | Profit | NOVARTIS PHARMA AG | Chirurgia Epatobiliare e dei Trapianti Epatici | Cillo Umberto | 4884/AO/20 | DDG n. 1334 del 02/10/2020 | 20/11/2020 | 13.850,00 € | 19/10/2022 | Curriculum | -- |
GS-US-428-4194 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjedts with Primary Sclerosing Cholangitis. | 2019-000204-14 | Profit | GILEAD SCIENCES INC. | Gastroenterologia | Farinati Fabio | 4868/AO/20 | DDG n. 980 del 17/07/2020 | 17/11/2020 | 6.635,00 € | 15/06/2023 | Curriculum | -- |
010906IN (LUMINA) | LUMINA: A Phase III, Multicenter, Sham-Controlled, Randomized, Double- Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ?g DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye. | 2019-003638-18 | Profit | SANTEN INCORPORATED | Clinica Oculistica | Leonardi Andrea | 4891/AO/20 | DDG n. 1330 del 02/10/2020 | 28/10/2020 | 13.924,00 € | 23/05/2022 | Curriculum | -- |
TD-1473 (0157) | A Phase 2b/3 Multi-Center, Randomized, Double Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD?1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis | 2018-002136-24 | Profit | THERAVANCE | Gastroenterologia | D'Inca' Renata | 4936/AO/20 | DDG n. 1328 del 02/10/2020 | 27/10/2020 | Fase induzione: 9,787,50 € Fase mantenimento: 6.083,75 € | 01/09/2021 | Curriculum | -- |
GA40209 | A phase II open-label extension study to evaluate the long-term safety and tolerability of uttr1147a in patients with moderate to severe ulcerative colitis or crohn's disease | 2017-004997-32 | Profit | GENENTECH , INC | Gastroenterologia | Savarino Edoardo Vincenzo | 4706/AO/19 | DDG n. 1331 del 02/10/2020 | 23/10/2020 | Paziente Non In Remissione Clinica: 7.235,00 € Paziente In Remissione Clinica: 3.214,00 € | 25/07/2022 | Curriculum | -- |
CC-10004-PPSO-004 | A Phase 3b, Multi Center, Open-label, Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects from 6 Through 17 Years of Age with Moderate to Severe Plaque Psoriasis | 2019-003497-13 | Profit | AMGEN INC. | Clinica Dermatologica | Belloni Fortina Anna | 4893/AO/20 | DDG n. 1124 del 24/08/2020 | 22/10/2020 | 5.845,00 € | -- | Curriculum | -- |
RPC01-3204 | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn?s Disease | 2017-004295-55 | Profit | CELGENE INTERNATIONAL SARL | Gastroenterologia | Savarino Edoardo Vincenzo | 4563/AO/18 | 18/09/2020 (ex DDG n. 203 del 20/03/2002) | 18/09/2020 | 5.303,70 € | -- | Curriculum | -- |
RPC01-3203 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn?s Disease | 2017-004294-14 | Profit | CELGENE INTERNATIONAL SARL | Gastroenterologia | Savarino Edoardo Vincenzo | 4587/AO/18 | 18/09/2020 (ex DDG n. 203 del 20/03/2002) | 18/09/2020 | 5.303,70 € | -- | Curriculum | -- |
LTE15174 (ATLAS-OLE) | ATLAS-OLE: An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients with emophilia A or B, with or without Inhibitory Antibodies to Factor VIII or IX | 2018-002880-25 | Profit | GENZYME | Coagulopatie | Zanon Ezio | 4889/AO/20 | DDG n. 1121 del 24/08/2020 | 16/09/2020 | 22.566,00 € | -- | Curriculum | -- |
0130A01SA | A Phase III, Multinational, Multicenter, Investigator-Masked, Randomised, Active-Controlled Trial, comparing the efficacy and safety of DE-130A with Xalatan® in Patients with Open-Angle Glaucoma or Ocular Hypertension over a 3-Month period, followed by a 12-Month Follow-Up with Open-Label DE-130A Treatment | 2017-004262-95 | Profit | Santen SAS | Clinica Oculistica | Leonardi Andrea | 4785/AO/19 | DDG n. 1156 del 28/08/2020 | 14/09/2020 | 3.658,00 € | 24/02/2022 | Curriculum | -- |
ABX464-104 | Studio di fase 2b, in aperto, per valutare l’efficacia e la sicurezza di ABX464 come terapia di mantenimento in pazienti con colite ulcerosa da moderata a grave. | 2019-000733-39 | Profit | ABIVAX | Gastroenterologia | Savarino Edoardo Vincenzo | 4886/AO/20 | DDG n. 1123 del 24/08/2020 | 14/09/2020 | 5.835,00 € | 02/03/2021 | Curriculum | -- |
SHP607-202 | Studio di fase 2b, multicentrico, randomizzato, in aperto, controllato, a 3 bracci per valutare l’efficacia clinica e la sicurezza di SHP607 nel prevenire la malattia polmonare cronica fino a 12 mesi di età corretta rispetto alle cure neonatali standard in neonati estremamente prematuri. | 2018-001393-16 | Profit | PREMACURE AB (SHIRE GROUP) | Patologia Neonatale | Baraldi Eugenio | 4867/AO/20 | DDG n. 1125 del 24/08/2020 | 14/09/2020 | Bracci Trattamento Sperimentale: 69.633,65 € Braccio Cure Neonatali Standard: 36.411,30 € | -- | Curriculum | -- |
KVD900-201 | A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II | 2018-004489-32 | Profit | KalVista Pharmaceuticals Ltd. | Clinica Medica 1 | Cancian Mauro | 4862/AO/20 | DDG n. 978 del 17/07/2020 | 04/08/2020 | 7.500,00 € | 23/03/2021 | Curriculum | -- |
V503-049 | A Phase 3, International, Multi-center, Randomized, Double-blind, Placebocontrolled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the prevention of oral persistent infection with HPV Types 16, 18, 31, 33, 45, 52, or 58 in adult males, 20 to 45 years of age | 2019-003236-23 | Profit | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Servizio per la Patologia della Riproduzione Umana | Foresta Carlo | 4876/AO/20 | DDG n. 1015 del 24/07/2020 | 04/08/2020 | 4.504,00 € | -- | Curriculum | -- |
EQ06.17.01 | Studio clinico multicentrico, randomizzato, in doppio cieco, doppio dummy, controllato verso placebo e verso farmaco attivo, con lo scopo di valutare l'efficacia di Tricortin 1000 in pazienti affetti da LBP cronico | 2018-002003-33 | Profit | FIDIA | Riabilitazione Ortopedica | Masiero Stefano | 4837/AO/20 | DDG n. 782 del 15/06/2020 | 10/07/2020 | 600,00 € | -- | Curriculum | -- |
ABX464-103 | Studio di induzione randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli e a dose multipla per valutare la sicurezza, la tollerabilità e la dose ottimale di ABX464 rispetto al placebo in pazienti affetti da colite ulcerosa da moderata a grave che hanno una risposta inadeguata, perdita della risposta, o intolleranza ad almeno uno dei seguenti agenti: trattamento con farmaci immunosoppressori (ad es. azatioprina, 6-mercaptopurina, metotrexato), inibitori del fattore di necrosi tumorale alfa [TNF-a], vedolizumab, inibitori di JAK e/o trattamento con corticosteroidi. | 2018-003558-26 | Profit | ABIVAX | Gastroenterologia | Savarino Edoardo Vincenzo | 4860/AO/20 | DDG n. 781 del 15/06/2020 | 29/06/2020 | 4.625,00 € | 29/07/2021 | Curriculum | -- |
CC-10004-PSOR-025 | A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects with Moderate to Severe Genital Psoriasis | 2018-002608-15 | Profit | CELGENE CORPORATION | Clinica Dermatologica | Piaserico Stefano | 4823/AO/20 | DDG n. 510 del 10/04/2020 | 18/05/2020 | 4.378,60 € | 14/04/2022 | Curriculum | -- |
NUC-5/PSC | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | 2016-003367-19 | Profit | DR. FALK PHARMA GMBH | Gastroenterologia | Farinati Fabio | 4618/AO/18 | DDG n. 414 del 19/03/2020 | 11/05/2020 | 10.000,00 € | -- | Curriculum | -- |
GA39925 | A phase 2, randomized, parallel-group, double-blind, double-dummy, placebo-controlled, multicenter study to evaluate the efficacy, safety and pharmacokinetics of UTTR1147A compared with placebo and compared with vedolizumab in patients with moderate to severe ulcerative colitis | 2017-002350-36 | Profit | GENENTECH , INC | Gastroenterologia | Savarino Edoardo Vincenzo | 4599/AO/18 | 27/04/2020 (ex DDG n. 203 del 20/03/2002) | 27/04/2020 | 6.396,00 € | 12/04/2022 | Curriculum | -- |
CLCZ696B2319E1 | A multicenter study to evaluate long-term safety and tolerability of open label sacubitril/valsartan in pediatric patients with heart failure due to systemic left ventricle systolic dysfunction who have completed study CLCZ696B2319 | 2018-004154-25 | Profit | NOVARTIS PHARMA AG | Cardiologia Pediatrica | Castaldi Biagio | 4734/AO/19 | DDG n. 282 del 20/02/2020 | 21/04/2020 | 7.850,00 € | -- | Curriculum | -- |
ALADDIN | Pathogenesis of Acute on Chronic Liver Failure (ACLF) and Mechanisms of Action of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) in Decompensated Cirrhotic Subjects with Systemic Inflammation and ACLF | 2017-002667-19 | No Profit | INSTITUTO GRIFOLS S.A. | Clinica Medica 5 | Angeli Paolo | 4753/AO/19 | DDG n. 1592 del 19/12/2019 | 14/04/2020 | Gruppo trattamento SMT 745,00 € Gruppo trattamento SMT+PE-A 2.475,00 € | -- | Curriculum | -- |
Eqol-MDS | Eltrombopag for the treatment of thrombocytopenia due to low- and intermediate risk myelodysplastic syndromes | 2010-022890-33 | No Profit | ASSOCIAZIONE QOL-ONE | Ematologia | Zambello Renato | 4121/AO/17 | 14/04/2020 (ex DDG n. 203 del 20/03/2002) | 14/04/2020 | 0,00 € | -- | Curriculum | -- |
EX9924-4473 | Semaglutide cardiovascular outcomes trial in patients with type 2 diabetes (SOUL) | 2018-003141-42 | Profit | NOVO NORDISK | Malattie del Metabolismo | Avogaro Angelo | 4810/AO/19 | DDG n. 59 del 16/01/2020 | 14/04/2020 | 6.790,00 € | -- | Curriculum | -- |
Z7219K01 | A 12-weeks, muticentre, randomized, double-blind, placebo-controlled, exploratory, pilot study to evaluate the safety and efficacy of safinamide 200 mg once dayly, as add-om therapy, in patients with possible or propbable parkinsonian variant of multiple system atrophy. | 2018-004145-16 | Profit | ZAMBON S.p.A. | Clinica Neurologica | Antonini Angelo | 4804/AO/19 | DDG n. 276 del 20/02/2020 | 06/04/2020 | 2.920,00 € | 10/02/2021 | Curriculum | -- |
SHP647-307 - CARMEN CD 307 | Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare efficacia e sicurezza di SHP647 come terapia di mantenimento in soggetti con malattia di Crohn da moderata a grave (CARMEN CD 307) | 2017-000617-23 | Profit | SHIRE HUMAN GENETIC THERAPIES, INC. | Gastroenterologia | Savarino Edoardo Vincenzo | 4703/AO/19 | DDG n. 283 del 20/02/2020 | 06/04/2020 | 8.005,17 € | 12/06/2020 | Curriculum | -- |
SHP647-305 - CARMEN CD 305 | Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare efficacia e sicurezza di SHP647 come terapia di induzione in soggetti con malattia di Crohn da moderata a grave (CARMEN CD 305) | 2017-000575-88 | Profit | SHIRE HUMAN GENETIC THERAPIES, INC. | Gastroenterologia | Savarino Edoardo Vincenzo | 4803/AO/19 | DDG n. 284 del 20/02/2020 | 06/04/2020 | 5.729,32 € | 12/06/2020 | Curriculum | -- |
747-401 | A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients with Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment | 2017-001762-13 | Profit | INTERCEPT PHARMACEUTICALS, INC. | Gastroenterologia | Farinati Fabio | 4575/AO/18 | DDG n. 279 del 20/02/2020 | 30/03/2020 | 14.198,30 € | -- | Curriculum | -- |
GS-US-540-5773 | A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Severe COVID-19 | 2020-000841-15 | Profit | GILEAD SCIENCE INC. | Malattie Infettive | Cattelan Annamaria | 4848/AO/20 | 43906 | 16/03/2020 | 8.256,00 € | 24/05/2020 | Curriculum | -- |
GS-US-540-5774 | A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Moderate COVID-19 Compared to Standard of Care Treatment | 2020-000842-32 | Profit | GILEAD SCIENCE INC. | Malattie Infettive | Cattelan Annamaria | 4849/AO/20 | 43906 | 16/03/2020 | 8.256,00 € | 28/05/2020 | Curriculum | -- |
NVG14L127 | A Phase IIIb, prospective, interventional, multicentre, three-year study to explore the long-term evolution of sign and symptoms, and occurrence of complications in Dry Eye Disease patients with severe keratitis receiving IKERVIS® (1mg/ml ciclosporin) eye drops | 2017-002660-41 | Profit | Santen SAS | Clinica Oculistica | Leonardi Andrea | 4786/AO/19 | DDG n. 60 del 16/01/2020 | 20/02/2020 | 5.414,00 € | -- | Curriculum | -- |
LIVERHOPE_EFFICACY | Efficacy of the combination of simvastatin plus rifaximin in patients whit decompensated cirrhosis to prevent ACLF development: multicenter, double-blind, placebo controlled randomized clinical trial | 2018-001698-25 | No Profit | IDIBAS | Clinica Medica 5 | Angeli Paolo | 4689/AO/19 | DDG n. 1593 del 19/12/2019 | 30/01/2020 | 215,40 € | 02/03/2023 | Curriculum | -- |
PRN1008-012 | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus | 2018-002261-19 | Profit | Principia Biopharma Inc. | Clinica Dermatologica | Alaibac Mauro Salvatore Alessandro | 4708/AO/19 | DDG n. 1591 del 19/12/2019 | 23/01/2020 | Periodo trattamento in cieco 6.061,77 € Periodo estensione in aperto 2.393,82 € | -- | Curriculum | -- |
DCR-PHXC-201(PHYOX 2) | A Phase 2 Placebo-Controlled, Double-Blind, multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of DCR-PHXC Solution for Injection (subcutaneous use) in Patients with Primary Hyperoxaluria - “PHYOX 2” | 2018-003098-91 | Profit | Dicerna Pharmaceuticals, Inc. | Nefrologia Pediatrica | Benetti Elisa | 4784/AO/19 | DDG n. 1598 del 19/12/2019 | 23/01/2020 | 9.523,80 € | 28/10/2020 | Curriculum | -- |
200075 (ZOSTER-047) | A Phase II, randomised, open-label, multicentre study to assess the reactogenicity, safety and immunogenicity of GSK's paediatric Herpes Zoster subunit candidate vaccine (PED-HZ/su) when administered intramuscularly on a two-dose schedule to immunocompromised paediatric renal transplant recipients from 1 to 17 years of age. | 2019-000607-33 | Profit | GLAXOSMITHKLINE BIOLOGICALS SA | Nefrologia Pediatrica | Murer Luisa | 4794/AO/19 | DDG n. 1594 del 19/12/2019 | 23/01/2020 | 2.600,00 € | -- | Curriculum | -- |
M15-741 | A 52-Week, open-label, single-arm study to evaluate the safety and tollerability of 24-hour daily exposure of continuos subcutaneos of ABBV-951 in subjects with Parkinson's disease | 2018-002144-85 | Profit | AbbVie Deutschland GmbH & Co. KG | Clinica Neurologica | Antonini Angelo | 4805/AO/19 | DDG n. 1587 del 19/12/2019 | 20/01/2020 | 8.113,00 € | -- | Curriculum | -- |
SNT-III-012-E ( SIDEROS-E) | A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study | 2017-004279-30 | Profit | SANTHERA PHARMACEUTICALS (SWITZERLAND) LTD | Clinica Neurologica | Pegoraro Elena | 4612/AO/18 | DDG n. 1382 del 08/11/2019 | 14/01/2020 | 3.029,00 € | 12/10/2020 | Curriculum | -- |
ID-054-304 | A prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the efficacy and safety of clazosentan in preventing clinical deterioration due to delayed cerebral ischemia (DCI), in adult subjects with aneurysmal subarachnoid hemorrhage (aSAH) | 2018-000241-39 | Profit | Idorsia Pharmaceuticals LTD | Anestesia e Rianimazione | Munari Marina | 4592/AO/18 | DDG n. 1388 del 08/11/2019 | 16/12/2019 | 12.610,00 € | -- | Curriculum | -- |
GS-US-367-1175 | A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed Dose Combination in Adolescents and Children with Chronic HCV Infection | 2018-000480-87 | Profit | GILEAD SCIENCE INC. | Clinica Pediatrica | Cananzi Mara | 4651/AO/18 | DDG n. 1383 del 08/11/2019 | 06/12/2019 | 3.209,00 € | 17/02/2020 | Curriculum | -- |
IM011023 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Crohn's Disease | 2017-001976-48 | Profit | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | Gastroenterologia | Savarino Edoardo Vincenzo | 4609/AO/18 | DDG n. 1207 del 04/10/2019 | 16/10/2019 | 10.086,00 € | -- | Curriculum | -- |
Lais-Birch-Alder-18-19 | Efficacia e sicurezza dell'immunoterapia sublinguale con compresse di Allergoide LAIS Birch per pazienti con rinocongiuntivite allergica indotta da polline d'albero in presenza o assenza di asma lieve controllato | 2018-002596-18 | Profit | LOFARMA | Medicina del Lavoro | Crivellaro Maria Angiola | 4642/AO/18 | DDG n. 605 del 24/05/2019 | 09/10/2019 | 1.200,00 € | -- | Curriculum | -- |
ALN-AT3SC-004 | ATLAS-A/B: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX | 2016-001464-11 | Profit | Alnylam Pharmaceuticals, Inc. | Coagulopatie | Zanon Ezio | 4479/AO/18 | DDG n. 1049 del 29/08/2019 | 03/10/2019 | Adulto Braccio Fitusiran 6.193,00 € Adulto Braccio On Demand 5.663,00 € Adulto - Perioperative 817,00 € Adolescente Braccio Fitusiran 6.313,00 € Adolescente On Demand Arm 5.783,00 € Adolescente Perioperative 819,00 € | 09/09/2021 | Curriculum | -- |
ALN-AT3SC-003 | ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients with Hemophilia A or B, with Inhibitory Antibodies to Factor VIII or IX | 2016-001463-36 | Profit | Alnylam Pharmaceuticals, Inc. | Coagulopatie | Zanon Ezio | 4480/AO/18 | DDG n. 1048 del 29/08/2019 | 03/10/2019 | Adulto Braccio Fitusiran 6.193,00 € Adulto Braccio On Demand 5.663,00 € Adulto - Perioperative 817,00 € Adolescente Braccio Fitusiran 6.313,00 € Adolescente On Demand Arm 5.783,00 € Adolescente Perioperative 819,00 € | 31/03/2020 | Curriculum | -- |
LAL2317 | NATIONAL TREATMENT PROGRAM WITH SEQUENTIAL CHEMOTHERAPY AND BLINATUMOMAB TO IMPROVE MINIMAL RESIDUAL DISEASE RESPONSE AND SURVIVAL IN PHILADELPHIA CHROMOSOME-NEGATIVE B-CELL PRECURSOR ADULT ACUTE LYMPHOBLASTIC LEUKEMIA | 2017-004251-23 | No Profit | Fondazione GIMEMA Onlus | Ematologia | Gurrieri Carmela | 4597/AO/18 | 01/10/2019 (ex DDG n. 203 del 20/03/2002) | 01/10/2019 | 0,00 € | -- | Curriculum | -- |
OSequIT | Multicentric Tandomized Clinical Trial of Deferasirox-Deferiprone Sequential Therapy versus Deferasirox or Deferiprone | 2016-004829-16 | No Profit | FONDAZIONE FRANCO E PIERA CUTINO | Clinica di Oncoematologia Pediatrica | Putti Maria Caterina | 4588/AO/18 | DDG n. 1053 del 29/08/2019 | 20/09/2019 | 573,77 € | -- | Curriculum | -- |
EX9536-4388-SELECT | Semaglutide effects on cardiovascular outcomes in people with overweight or obesity | 2017-003380-85 | Profit | NOVO NORDISK | Medicina Generale a indirizzo Endocrino-Metabolico | Vettor Roberto | 4672/AO/19 | DDG n. 1052 del 29/08/2019 | 17/09/2019 | 8.500,00 € | -- | Curriculum | -- |
CLI/22 | A, randomised, double-blind, parallel-group, multicenter, placebo-controlled, dose-ranging study, to evaluate efficacy and safety of clodronate ampoules at different dosages, after intra-articular administrations to patients affested by knee osteoarthritis | 2018-002081-39 | Profit | ABIOGEN PHARMA | Reumatologia | Ramonda Roberta | 4687/AO/19 | DDG n. 897 del 25/07/2019 | 17/09/2019 | 2.800,00 € | -- | Curriculum | -- |
BASTA - LPS15198 | Studio clinico di Fase IV, randomizzato, in doppio cieco, multicentrico, controllato verso placebo per valutare l?efficacia e la sicurezza di enterogermina (Bacillus clausii) nel trattamento di pazienti con aumentata crescita batterica a livello dell?intestino tenue | 2018-001355-12 | Profit | SANOFI-AVENTIS GROUPE | Gastroenterologia | Savarino Edoardo Vincenzo | 4667/AO/19 | DDG n. 877 del 19/07/2019 | 10/09/2019 | 2.500,00 € | 31/12/2019 | Curriculum | -- |
CLCI699C2X01B | An open-label, multi-center, roll-over study to assess long term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat | 2017-002840-34 | Profit | NOVARTIS PHARMA AG | Endocrinologia | Scaroni Carla | 4727/AO/19 | DDG n. 881 del 19/07/2019 | 09/08/2019 | 2.800,00 € | -- | Curriculum | -- |
CNTO1959PSA3003 | Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants with Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF?) Therapy | 2018-003214-41 | Profit | JANSSEN CILAG INTERNATIONAL NV | Reumatologia | Ramonda Roberta | 4704/AO/19 | DDG n. 879 del 19/07/2019 | 09/08/2019 | 6.842,00 € | -- | Curriculum | -- |
CC-10004-PPSO-003 | A phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of apremilast (CC-10004) in pediatric subjects from 6 through 17 years of age with moderate tosevere plaque psoriasis | 2018-002918-12 | No Profit | CELGENE CORPORATION | Clinica Dermatologica | Belloni Fortina Anna | 4688/AO/19 | DDG n. 880 del 19/07/2019 | 31/07/2019 | 12.484,00 € | -- | Curriculum | -- |
1293-0013 | An exploratory maintenance trial evaluating the effect of BI 655064 in Lupus Nephritis patients who have achieved a meaningful response either at the end of 1293.10 or after an induction treatment outside of 1293.10 | 2017-003101-17 | Profit | BOEHRINGER ING. | Reumatologia | Doria Andrea | 4711/AO/19 | DDG n. 690 del 07/06/2019 | 25/07/2019 | 3.600,00 € | -- | Curriculum | -- |
IELSG 40 | Studio di Fase II di fattibilita della combinazione claritromicina + lenalidomide: un trattamento orale per pazienti con linfoma del tessuto linfoide associato alla mucosa (MALT) recidivante o refrattario (Studio CLEO) | 2015-003168-35 | No Profit | INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP (IELSG) | Ematologia | Zambello Renato | 4545/AO/18 | 19/07/2019 (ex DDG n. 203 del 20/03/2002) | 19/07/2019 | 0,00 € | -- | Curriculum | -- |
E2027-G000-201 | A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies | 2017-003728-64 | Profit | EISAI INC. | Clinica Neurologica | Antonini Angelo | 4679/AO/19 | DDG n. 720 del 21/06/2019 | 15/07/2019 | 6.867,00 € | -- | Curriculum | -- |
IG 1407 (APACHE) | Effects of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) on Shortterm Survival in Subjects with "Acute-On-Chronic Liver Failure" (ACLF) at High Risk of Hospital Mortality | 2016-001787-10 | Profit | INSTITUTO GRIFOLS S.A. | Clinica Medica 5 | Angeli Paolo | 4619/AO/18 | DDG n. 606 del 24/05/2019 | 01/07/2019 | Gruppo trattamento SMT 7.200,00 € Gruppo trattamento SMT+PE-A 18.765,00 € | -- | Curriculum | -- |
EsPhALL2017/COGAALL1631 | International phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones | 2017-000705-20 | No Profit | UNIVERSITA' DEGLI STUDI DI MILANO - BICOCCA | Clinica di Oncoematologia Pediatrica | Putti Maria Caterina | 4469/AO/18 | 24/06/2019 (ex DDG n. 203 del 20/03/2002) | 24/06/2019 | 0,00 € | -- | Curriculum | -- |
CB8025-31735 | Studio di fase 3, di 52 settimane, randomizzato, controllato con placebo, per valutare la sicurezza e l'efficacia di seladelpar in soggetti affetti da colangite biliare primitiva (CBP) che presentano una risposta inadeguata o intolleranza all'acido ursodesossicolico (UDCA) | 2018-001171-20 | Profit | CymaBay Therapeutics, Inc. | Gastroenterologia | Floreani Annarosa | 4649/AO/18 | DDG n. 640 del 31/05/2019 | 24/06/2019 | 3.958,34 € | 16/01/2020 | Curriculum | -- |
APIDULCIS | APIDULCIS: Terapia estesa con bassa dose di apixaban in pazienti con un primo evento di tromboembolismo venoso che hanno gia effettuato il periodo standard di anticoagulazione e che hanno D-dimero positivo | 2017-002340-32 | No Profit | FONDAZIONE ARIANNA ANTICOAGULAZIONE | Angiologia | Avruscio Giampiero | 4558/AO/18 | 20/06/2019 (ex DDG n. 203 del 20/03/2002) | 20/06/2019 | 0,00 € | 25/06/2020 | Curriculum | -- |
APIDULCIS | APIDULCIS: Terapia estesa con bassa dose di apixaban in pazienti con un primo evento di tromboembolismo venoso che hanno gia effettuato il periodo standard di anticoagulazione e che hanno D-dimero positivo | 2017-002340-32 | No Profit | FONDAZIONE ARIANNA ANTICOAGULAZIONE | Cardiologia | Pengo Vittorio | 4559/AO/18 | 20/06/2019 (ex DDG n. 203 del 20/03/2002) | 20/06/2019 | 0,00 € | 25/06/2020 | Curriculum | -- |
APIDULCIS | APIDULCIS: Terapia estesa con bassa dose di apixaban in pazienti con un primo evento di tromboembolismo venoso che hanno gia effettuato il periodo standard di anticoagulazione e che hanno D-dimero positivo | 2017-002340-32 | No Profit | FONDAZIONE ARIANNA ANTICOAGULAZIONE | Clinica Medica 3 | Pesavento Raffaele | 4560/AO/18 | 19/06/2019 (ex DDG n. 203 del 20/03/2002) | 19/06/2019 | 0,00 € | -- | Curriculum | -- |
EMN18 | A multicenter, open label, randomized phase II study comparing daratumumab combined with bortezomib-cyclophosphamide-dexamethasone (Dara-VCd) versus the association of bortezomib-thalidomide-dexamethasone (VTd) as pre transplant induction and post transplant consolidation, both followed by a maintenance phase with ixazomib alone or in combination with daratumumab, in newly diagnosed multiple myeloma (MM) young patients eligible for autologous stem cell transplantation. | 2018-002089-37 | Profit | E.M.N. - EUROPEAN MYELOMA NETWORK | Ematologia | Zambello Renato | 4613/AO/18 | DDG n. 638 del 31/05/2019 | 11/06/2019 | 1.262,00 € | -- | Curriculum | -- |
CCFZ533A2201 (CIRRUS I) | A 12 month, partially-blinded, active-controlled, multicenter, randomized study evaluating efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) of an anti-CD40 monoclonal antibody, CFZ533, in de novo and maintenance kidney transplant recipients (CIRRUS I) | 2017-003607-22 | Profit | NOVARTIS FARMA | Trapianti di Rene e Pancreas | Rigotti Paolo | 4572/AO/18 | DDG n. 559 del 22/05/2019 | 11/06/2019 | Coorte 1 6.150,00 € Coorte 2 5.850,00 € | 24/03/2021 | Curriculum | -- |
FIL_V-RBAC | Rituximab, bendamustina e citarabina seguiti da venetoclax (V-RBAC) in pazienti anziani, ad alto rischio con linfoma mantellare | 2017-004628-31 | No Profit | FONDAZIONE ITALIANA LINFOMI ONLUS | Ematologia | Piazza Francesco | 4574/AO/18 | 10/06/2019 (ex DDG n. 203 del 20/03/2002) | 10/06/2019 | 0,00 € | -- | Curriculum | -- |
CRTH258B2301 | A Two-Year, Three-Arm, Randomized, Double-Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab versus Aflibercept in Adult Patients with Visual Impairment due to Diabetic Macular Edema | 2017-004742-23 | Profit | NOVARTIS FARMA | Clinica Oculistica | Midena Edoardo | 4569/AO/18 | DDG n. 560 del 22/05/2019 | 07/06/2019 | 29.090,00 € | -- | Curriculum | -- |
RPC01-3201 | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn?s Disease | 2017-004292-31 | Profit | CELGENE INTERNATIONAL SARL | Gastroenterologia | Savarino Edoardo Vincenzo | 4531/AO/18 | 07/06/2019 (ex DDG n. 203 del 20/03/2002) | 07/06/2019 | 5.878,19 € | -- | Curriculum | -- |
241502 | A Phase 3, Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (BAX 802) in Subjects with Congenital Hemophilia A with Factor VIII Inhibitors Undergoing Surgical or Other Invasive Procedures | 2015-005521-39 | Profit | BAXALTA INNOVATIONS GmbH | Coagulopatie | Zanon Ezio | 4149/AO/17 | 16/05/2019 (ex DDG n. 203 del 20/03/2002) | 16/05/2019 | 11.716,00 € | -- | Curriculum | -- |
MYL-1603N-3002 | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-center Study to Compare the Anti-Depressive Efficacy and Safety of Samyr? IM versus Placebo IM as an Enhancer Adjunctive to Antidepressant Treatment in Major Depression Disorder Patients Who have not Experienced Sufficient Symptoms Improvement Despite Antidepressant Treatment | 2017-003074-14 | Profit | MYLAN INC. | Psichiatria 3 | Toffanin Tommaso | 4573/AO/18 | DDG n. 115 del 01/02/2019 | 16/05/2019 | 7.977,06 € | -- | Curriculum | -- |
CSEG101B2201 | A phase 2, Multicenter, Open-Label Study to Assess Appropriate Dosing and to Evaluate Safety of Crizanlizumab, with or without Hydroxyurea/Hydroxycarbamide, in Sequential, Descending Age Groups of Pediatric Sickle Cell Disease Patients with Vaso-Occlusive Crisis | 2017-001747-12 | Profit | NOVARTIS FARMA | Clinica di Oncoematologia Pediatrica | Colombatti Raffaella | 4670/AO/19 | DDG n. 502 del 02/05/2019 | 14/05/2019 | 17.680,00 € | -- | Curriculum | -- |
LTS14424 - LIBERTY ASTHMA EXCURSION | Studio di un anno volto a valutare la sicurezza e la tollerabilita a lungo termine di Dupilumab in pazienti pediatrici che abbiano partecipato a un precedente studio clinico con dupilumab nell'asma | 2017-003317-25 | Profit | SANOFI-AVENTIS S.P.A | Pneumologia e Allergologia Pediatrica | Zanconato Stefania | 4647/AO/18 | DDG n. 304 del 18/03/2019 | 09/05/2019 | 6.950,00 € | 01/03/2022 | Curriculum | -- |
A4250-008 | An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2) | 2017-002325-38 | Profit | Albireo AB | Clinica Pediatrica | Cananzi Mara | 4643/AO/18 | DDG n. 305 del 18/03/2019 | 06/05/2019 | 6.660,72 € | 10/11/2022 | Curriculum | -- |
53718678RSV2002 | A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children ?28 Days and ?3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection | 2016-003642-93 | Profit | Janssen Sciences Ireland UC | Patologia Neonatale | Baraldi Eugenio | 4648/AO/18 | DDG n. 261 del 01/03/2019 | 17/04/2019 | Coorte 1 6.074,00 € Coorte 2 2.808,00 € | 14/04/2022 | Curriculum | -- |
GEDACNE | A double-blind, randomized, vehicle-controlled clinical multi-center study to evaluate the efficacy and safety of N-Acetyl-GED-0507-34-LEVO gel, 2 and 5%, applied once daily for 12 weeks in patients with facial acne vulgaris | 2018-003307-18 | Profit | PPM SERVICES SA | Clinica Dermatologica | Belloni Fortina Anna | 4650/AO/18 | DDG n. 306 del 18/03/2019 | 12/04/2019 | 1.800,00 € | -- | Curriculum | -- |
RAP-ALS | RAPAMYCIN (SIROLIMUS) TREATMENT FOR AMYOTROPHIC LATERAL SCLEROSIS | 2016-002399-28 | No Profit | AZIENDA OSPEDALIERA POLICLINICO DI MODENA | Clinica Neurologica | Sorarù Gianni | 4404/AO/18 | 03/04/2018 (ex DDG n. 203 del 20/03/2002) | 03/04/2019 | 1.335,85 € | -- | Curriculum | -- |
1368-0017 | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | 2018-000334-35 | Profit | BOEHRINGER INGELHEIM INTERNATIONAL GMBH | Gastroenterologia | Savarino Edoardo Vincenzo | 4644/AO/18 | DDG n. 138 del 07/02/2019 | 26/03/2019 | Pazienti Responder studio 1368-0005: 12.100,00 € Pazienti Non Responder studio 1368-0005: 13.400,00 € Pazienti Non Responder studio 1368-0005 e presente studio: 2.300,00 € Pazienti con riacutizzazione: 16.500,00 € | -- | Curriculum | -- |
B7981005 | A phase 2B, double-blind, randomized, placebo-controlled, parallel group, dose ranging study of oral PF-06651600 and PF-06700841 as induction and chronic therapy in subjects with moderate to severe ulcerative colitis | 2016-003708-29 | Profit | PFIZER INC. | Gastroenterologia | Savarino Edoardo Vincenzo | 4546/AO/18 | 26/02/2019 (ex DDG n. 203 del 20/03/2002) | 26/02/2019 | 5.632,96 € | 29/06/2021 | Curriculum | -- |
MSK-003 | Long Term Safety Study of Amifampridine Phosphate in Patients with MuSK Antibody Positive and AChR Antibody Positive Myasthenia Gravis Patients | 2017-004777-14 | Profit | Catalyst Pharmaceuticals INC. | Clinica Neurologica | Pegoraro Elena | 4585/AO/18 | DDG n. 40 del 21/01/2019 | 22/02/2019 | 8.000,00 € | 20/10/2021 | Curriculum | -- |
AG-221-AML-004 (IDHENTIFY) | A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects with Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation | 2015-000344-42 | Profit | CELGENE CORPORATION | Ematologia | Lessi Federica | 4535/AO/18 | 21/02/2019 (ex DDG n. 203 del 20/03/2002) | 21/02/2019 | Pazienti BSC 10.440,00 € Pazienti AG-221 10.710,00 € Pazienti LDAC 18.216,00 € Pazienti IDAC 17.179,20 € Pazienti AZA 15.883,20 | 30/09/2019 | Curriculum | -- |
A4250-005 | A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1) | 2017-002338-21 | Profit | Albireo AB | Clinica Pediatrica | Cananzi Mara | 4527/AO/18 | 30/01/2019 (ex DDG n. 203 del 20/03/2002) | 30/01/2019 | 4.828,21 € | 21/07/2020 | Curriculum | -- |
DU-176B-C-U4001 | Edoxaban rispetto a standard di cura e rispettivi effetti sugli esiti clinici in pazienti sottoposti a impianto transcatetere di valvola aortica nella fibrillazione atriale (Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation In Atrial Fibrillation) | 2016-003930-26 | Profit | Daiichi Sankyo, Inc. | Cardiologia | Tarantini Giuseppe | 4537/AO/18 | 25/01/2019 (ex DDG n. 203 del 20/03/2002) | 25/01/2019 | 3.086,58 € | -- | Curriculum | -- |
MN39159 | STUDIO IN APERTO, A SINGOLO BRACCIO, DELLA DURATA DI 4 ANNI, PER VALUTARE L'EFFICACIA E LA SICUREZZA DEL TRATTAMENTO CON OCRELIZUMAB IN PAZIENTI CON SCLEROSI MULTIPLA PROGRESSIVA | 2017-001313-93 | Profit | F. HOFFMANN - LA ROCHE LTD. | Clinica Neurologica | Gallo Paolo | 4532/AO/18 | 23/01/2019 (ex DDG n. 203 del 20/03/2002) | 23/01/2019 | 16.700,00 € | -- | Curriculum | -- |
HPN-100-021 | A Randomised, Controlled, Open-Label Parallel Arm Study of the Safety, Pharmacokinetics and Ammonia Control of RAVICTI? (Glycerol Phenylbutyrate [GPB]) Oral Liquid and Sodium Phenylbutyrate (NaPBA) in Phenylbutyrate Treatment Naive Patients with Urea Cycle Disorders (UCDs) | 2015-000075-27 | Profit | Horizon Therapeutics, LLC | Malattie Metaboliche ed Ereditarie | Burlina Alberto | 4544/AO/18 | DDG n. 1485 del 03/12/2018 | 21/01/2019 | 11.188,81 € | 15/03/2021 | Curriculum | -- |
IG1601 (PRECIOSA) | Prevention of Mortality with Long-Term Administration of Human Albumin in Subjects with Decompensated Cirrhosis and Ascites | 2016-001789-28 | Profit | INSTITUTO GRIFOLS S.A. | Clinica Medica 5 | Angeli Paolo | 4497/AO/18 | 11/01/2019 (ex DDG n. 203 del 20/03/2002) | 11/01/2019 | Gruppo di trattamento: 13.410,00 € Gruppo di controllo: 7.010,00 € | -- | Curriculum | -- |
SHP647-304 | Studio di estensione di fase 3, per valutare la sicurezza a lungo termine di SHP647 in soggetti con colite ulcerosa o malattia di Crohn da moderata a grave (AIDA). | 2017-000574-11 | Profit | SHIRE HUMAN GENETIC THERAPIES, INC. | Gastroenterologia | Savarino Edoardo Vincenzo | 4427/AO/18 | 08/01/2019 (ex DDG n. 203 del 20/03/2002) | 08/01/2019 | I° anno: 6.127,78 € II° anno e seg.: 6.801,10 € | -- | Curriculum | -- |
SHP647-303 | Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare efficacia e sicurezza di SHP647 come terapia di mantenimento in soggetti con colite ulcerosa da moderata a grave (FIGARO UC 303) | 2017-000573-37 | Profit | SHIRE HUMAN GENETIC THERAPIES, INC. | Gastroenterologia | Savarino Edoardo Vincenzo | 4429/AO/18 | 08/01/2019 (ex DDG n. 203 del 20/03/2002) | 08/01/2019 | 7.895,90 € | 07/09/2021 | Curriculum | -- |
CNTO1275CRD3007 (SEAVUE) | A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naive Subjects with Moderately-to-Severely Active Crohn?s Disease | 2017-004209-41 | Profit | JANSSEN-CILAG INTERNATIONAL N.V. | Gastroenterologia | Savarino Edoardo Vincenzo | 4555/AO/18 | DDG n. 1486 del 03/12/2018 | 31/12/2018 | 7.641,00 € | -- | Curriculum | -- |
MN39158 | A single arm, open label multicentre extension study to evaluate the effectiveness and safety of ocrelizumab in patients with multiple sclerosis previously enrolled in A F. HOFFMANN-LA ROCHE sponsored ocrelizumab phase IIIb/IV clinical trial | 2017-004886-29 | Profit | F. HOFFMANN - LA ROCHE LTD. | Clinica Neurologica | Gallo Paolo | 4565/AO/18 | 19/12/2018 (ex DDG n. 203 del 20/03/2002) | 19/12/2018 | 5.900,00 € | 27/01/2022 | Curriculum | -- |
SHP647-301 | Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare efficacia e sicurezza di SHP647 come terapia di induzione in soggetti con colite ulcerosa da moderata a grave (FIGARO UC 301) | 2017-000599-27 | Profit | SHIRE HUMAN GENETIC THERAPIES, INC. | Gastroenterologia | Savarino Edoardo Vincenzo | 4428/AO/18 | 14/12/2018 (ex DDG n. 203 del 20/03/2002) | 14/12/2018 | 4.325,74 € | 18/09/2020 | Curriculum | -- |
MSK-002 | A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients with MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Positive Myasthenia Gravis Patients. | 2017-004018-25 | Profit | Catalyst Pharmaceuticals INC. | Clinica Neurologica | Pegoraro Elena | 4426/AO/18 | DDG n. 1344 del 29/10/2018 | 12/12/2018 | 4.630,00 € | 22/09/2020 | Curriculum | -- |
GMPO-131-002 (CHELATE STUDY) | Trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson's disease. | 2016-003876-29 | Profit | GMP-Orphan SAS | Gastroenterologia | D'Inca' Renata | 4361/AO/17 | 12/12/2018 (ex DDG n. 203 del 20/03/2002) | 12/12/2018 | 4.891,30 € | 13/04/2021 | Curriculum | -- |
D5136C00009 | Uno studio di fase III, randomizzato, in doppio cieco, a gruppi paralleli, multicentrico, per valutare l?effetto di ticagrelor rispetto a placebo nel ridurre il tasso di crisi vaso-occlusive in pazienti pediatrici affetti da anemia falciforme (HESTIA3) | 2017-002421-38 | Profit | ASTRAZENECA AB | Clinica di Oncoematologia Pediatrica | Colombatti Raffaella | 4524/AO/18 | 11/12/2018 (ex DDG n. 203 del 20/03/2002) | 11/12/2018 | 5.361,00 € | -- | Curriculum | -- |
ACP-103-045 | A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis | 2017-002227-13 | Profit | ACADIA PHARMACEUTICALS INC. | Clinica Neurologica | Antonini Angelo | 4554/AO/18 | 05/12/2018 (ex DDG n. 203 del 20/03/2002) | 05/12/2018 | 13.679,88 € | -- | Curriculum | -- |
B7581002 (BUILD UC) | A phase 2a, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234 as add-on therapy to infliximab in active ulcerative colitis subjects who are not in remission (BUILD UC) | 2017-002108-28 | Profit | PFIZER INC. | Gastroenterologia | Savarino Edoardo Vincenzo | 4515/AO/18 | 04/12/2018 (ex DDG n. 203 del 20/03/2002) | 04/12/2018 | 4.093,13 € | -- | Curriculum | -- |
B7981007 | A phase 2a, double-blind, randomized, placebo-controlled parallel group study to evaluate the efficacy and safety of oral PF-06651600 and PF-06700841 as induction and open label extension treatment in subjects with moderate to severe Crohn's disease. | 2017-003359-43 | Profit | PFIZER INC. | Gastroenterologia | Savarino Edoardo Vincenzo | 4530/AO/18 | 04/12/2018 (ex DDG n. 203 del 20/03/2002) | 04/12/2018 | Fase induzione: 5.354,72 € Fase estensione: 4.696,16 € | 07/03/2023 | Curriculum | -- |
CNTO1959PSO3011 (PROTOSTAR) | A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects (?6 To <18 Years of Age) | 2017-003053-42 | Profit | JANSSEN-CILAG INTERNATIONAL N.V. | Clinica Dermatologica | Belloni Fortina Anna | 4553/AO/18 | DDG n. 1343 del 29/10/2018 | 14/11/2018 | Parte 1: 18.422,00 € Parte 2: 16.451,00 € | -- | Curriculum | -- |
NH19708 | An open-label, single-arm, multicenter study to ascertain the optimal starting dose of MIRCERA? given subcutaneously for the maintenance treatment of anemia in pediatric patients with chronic kidney disease on dialysis or not yet on dialysis | 2016-004779-39 | Profit | F. HOFFMANN - LA ROCHE LTD. | Nefrologia Pediatrica | Murer Luisa | 4522/AO/18 | 14/11/2018 (ex DDG n. 203 del 20/03/2002) | 14/11/2018 | 4.400,00 € | 31/10/2019 | Curriculum | -- |
Vedolizumab-4004 (EARNEST) | A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)- Vedolizumab IV 300 mg in the Treatment of Chronic Pouchitis | 2015-003472-78 | Profit | TAKEDA EUROPE RESEARCH & DEVELOPMENT CENTRE LTD | Gastroenterologia | Savarino Edoardo Vincenzo | 4478/AO/18 | 12/11/2018 (ex DDG n. 203 del 20/03/2002) | 12/11/2018 | 8.284,00 € | 19/04/2021 | Curriculum | -- |
IM101611 | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM). | 2016-002269-77 | Profit | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | Reumatologia | Doria Andrea | 4343/AO/17 | 12/11/2018 (ex DDG n. 203 del 20/03/2002) | 12/11/2018 | 8.421,00 € | 13/12/2022 | Curriculum | -- |
1368-0005 | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | 2017-004230-28 | Profit | BOEHRINGER ING. | Gastroenterologia | Savarino Edoardo Vincenzo | 4449/AO/18 | 08/11/2018 (ex DDG n. 203 del 20/03/2002) | 08/11/2018 | Paziente di Fase II: 4.600,00 € Paziente di Fase III: 4.800,00 € | 15/09/2020 | Curriculum | -- |
ARC008 | A Multicenter, Open-Label, Long-Term Safety Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study | 2017-001334-26 | Profit | AIMMUNE THERAPEUTICS Inc | U.O.S.D. Allergie Alimentari | Muraro Maria Antonella | 4498/AO/18 | 23/10/2018 (ex DDG n. 203 del 20/03/2002) | 23/10/2018 | Braccio trattamento 1: 11.968,86 € Braccio trattamento 2: 24.897,60 € Braccio trattamento 3: 37.280,63 € | -- | Curriculum | -- |
1199.225 (SENSCIS TM- ON) | An open-label extension trial to assess the long term safety of nintedanib in patients with `Systemic Sclerosis associated Interstitial Lung Disease' (SSc-ILD). | 2016-003403-66 | Profit | BOEHRINGER ING. | Reumatologia | Iaccarino Luca | 4381/AO/17 | 19/10/2018 (ex DDG n. 203 del 20/03/2002) | 19/10/2018 | 9.550,00 € | -- | Curriculum | -- |
BCX7353-204 | An open-label study to evaluate the long-term safety of daily oral BCX7353 in subjects with Type I and II hereditary angioedema | 2017-003281-27 | Profit | BIOCRYST PHARMACEUTICALS INC. | Clinica Medica 1 | Cancian Mauro | 4464/AO/18 | 11/10/2018 (ex DDG n. 203 del 20/03/2002) | 11/10/2018 | 7.265,00 € | -- | Curriculum | -- |
GS-US-419-3896 | Studio di estensione a lungo termine per la valutazione della sicurezza di Filgotinib in soggetti con morbo di Crohn | 2016-002763-34 | Profit | GILEAD SCIENCE INC. | Gastroenterologia | D'Inca' Renata Dal 01/07/2021 Fabiana Zingone | 4101/AO/17 | 11/10/2018 (ex DDG n. 203 del 20/03/2002) | 11/10/2018 | 14.271,00 € | -- | Curriculum | -- |
GS-US-419-3895 | Studi combinati di fase 3, in doppio cieco, randomizzati, controllati con placebo, per la valutazione dell'efficacia e della sicurezza di Filgotinib nell'induzione e nel mantenimento della remissione in soggetti con morbo di Crohn attivo di grado da moderato a severo | 2016-001367-36 | Profit | GILEAD SCIENCE INC. | Gastroenterologia | D'Inca' Renata Dal 01/07/2021 Fabiana Zingone | 4102/AO/17 | 11/10/2018 (ex DDG n. 203 del 20/03/2002) | 11/10/2018 | 23.759,00 € | 20/03/2023 | Curriculum | -- |
CPKC412A2408 | STUDIO IN APERTO, MULTICENTRICO, DI FASE IIIb PER VALUTARE LA SICUREZZA D'IMPIEGO E L'EFFICACIA DI MIDOSTAURINA (PKC412) IN PAZIENTI DI ETA UGUALE O SUPERIOR A 18 ANNI CON LEUCEMIA MIELOIDE ACUTA CON FLT3-MUTATO DI NUOVA DIAGNOSI CHE SONO ELEGGIBILI ALLA CHEMIOTERAPIA "7+3" O "5+2" | 2016-004440-12 | Profit | NOVARTIS PHARMA AG | Ematologia | Gurrieri Carmela | 4511/AO/18 | 28/09/2018 (ex DDG n. 203 del 20/03/2002) | 28/09/2018 | 20.000,00 € | -- | Curriculum | -- |
MERISUDD | Efficacy and safety of mesalazine, rifaximin, alone or as extemporary combination, in the treatment of symptomatic uncomplicated diverticular disease of colon: multi-centre, randomised, double-blind, double - dummy, parallel group, placebo-controlled study (MERISUDD study). | 2016-004159-56 | No Profit | Dipartimento di Medicina Clinica e Chirurgia - Universita degli Studi di Napoli Federico II | Gastroenterologia | Savarino Edoardo Vincenzo | 4265/AO/17 | 27/07/2018 (ex DDG n. 203 del 20/03/2002) | 27/07/2018 | 0,00 € | 16/10/2019 | Curriculum | -- |
GS-US-418-3899 | Studio di estensione a lungo termine per la valutazione della sicurezza di filgotinib in soggetti affetti da colite ulcerosa | 2016-002765-58 | Profit | GILEAD SCIENCE INC. | Gastroenterologia | D'Inca' Renata Dal 01/07/2021 Fabiana Zingone | 4067/AO/17 | 24/07/2018 (ex DDG n. 203 del 20/03/2002) | 24/07/2018 | 14.496,00 € | -- | Curriculum | -- |
BAY 1142524 / 18933 | A randomized, double-blind, multicenter study to assess the efficacy and safety of a 6 month oral treatment with the chymase inhibitor BAY 1142524 at a dose of 25 mg BID in comparison to placebo on top of standard of care in patients with type II diabetes and a clinical diagnosis of diabetic kidney disease. | 2017-000656-26 | Profit | Bayer AG | Malattie del Metabolismo | Avogaro Angelo | 4342/AO/17 | 24/07/2018 (ex DDG n. 203 del 20/03/2002) | 24/07/2018 | 7.393,50 € | 03/12/2019 | Curriculum | -- |
D3250C00045 | Studio di Fase 3b multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo per valutare la sicurezza e l'efficacia di benralizumab 30 mg per via sottocutanea in pazienti affetti da asma grave non controllabile con il trattamento standard | 2017-001040-35 | Profit | ASTRAZENECA AB | Medicina del Lavoro | Maestrelli Piero Dal 01/10/2019 Guarnieri Gabriella | 4326/AO/17 | 06/07/2018 (ex DDG n. 203 del 20/03/2002) | 06/07/2018 | 5.348,00 € | -- | Curriculum | -- |
TAK-831-2002 | A Phase 2, 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of 3 Dose levels of TAK-831 in Adjunctive Treatment of Adult Subjects With Negative Symptoms of Schizophrenia | 2017-003471-54 | Profit | Millennium Pharmaceuticals | Psichiatria 3 | Pigato Giorgio | 4463/AO/18 | 05/07/2018 (ex DDG n. 203 del 20/03/2002) | 05/07/2018 | 11.175,25 € | 18/03/2021 | Curriculum | -- |
BXU513667 | A Randomized Controlled Non-inferiority Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or Reducing Postoperative Air Leaks After Pulmonary Resection. | 2017-003931-12 | Profit | Baxter Healthcare Corporation | Chirurgia Toracica | Rea Federico | 4405/AO/18 | 02/07/2018 (ex DDG n. 203 del 20/03/2002) | 02/07/2018 | 5.007,00 € | 21/06/2019 | Curriculum | -- |
GBT440-034 | An Open Label Extension Study of GBT440 Administered Orally to Patients with Sickle Cell Disease Who Have Participated in GBT440 Clinical Trials | 2017-004045-25 | Profit | Clobal Blood Therapeutics | Clinica di Oncoematologia Pediatrica | Colombatti Raffaella | 4432/AO/18 | 29/06/2018 (ex DDG n. 203 del 20/03/2002) | 29/06/2018 | 2.930,00 € | -- | Curriculum | -- |
REDIV/002/17 | Rifaximina, compresse a rilascio ritardato da 400 mg, nella prevenzione della recidiva di diverticolite acuta e delle complicanze diverticolari. Studio randomizzato di fase II, multicentrico, in doppio cieco, controllato verso placebo. | 2017-002708-28 | Profit | Alfasigma S.p.A. | Gastroenterologia | Savarino Edoardo Vincenzo | 4420/AO/18 | 14/06/2018 (ex DDG n. 203 del 20/03/2002) | 14/06/2018 | 4.000,00 € | 03/12/2019 | Curriculum | -- |
ARES | Novel strategies of antithrombotic prophylaxis in patients with essential thrombocythemia at high risk of cardiovascular events: comparison of different dosing regimens of administration of low-dose acetylsalicylic acid | 2016-002885-30 | No Profit | UNIVERSITA' CATTOLICA DEL SACRO CUORE - POLICLINICO GEMELLI (UCSC) | Clinica Medica 1 | Randi Maria Luigia | 4038/AO/17 | 12/06/2018 (ex DDG n. 203 del 20/03/2002) | 12/06/2018 | 800,00 € | -- | Curriculum | -- |
MK-8228-002-01 | A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients | 2017-001055-30 | Profit | MERCK SHARP & DOHME CORP. | Trapianti di Rene e Pancreas | Rigotti Paolo | 4431/AO/18 | 17/05/2018 (ex DDG n. 203 del 20/03/2002) | 17/05/2018 | 17.523,00 € | 05/04/2022 | Curriculum | -- |
FADOI.01.2016 PROLAPS II | Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer: a randomized, double blind, placebo-controlled study. THE PRO-LAPS STUDY II. | 2015-005090-20 | No Profit | Fondazione FADOI | Angiologia | Avruscio Giampiero | 4094/AO/17 | 19/04/2018 (ex DDG n. 203 del 20/03/2002) | 19/04/2018 | 350,00 € | 04/02/2022 | Curriculum | -- |
RNS60-ALS | The effects of RNS60 on ALS biomarkers | 2016-002382-62 | No Profit | IST. DI RICERCHE FARMACOLOG. M. NEGRI | Clinica Neurologica | Sorarù Gianni | 4182/AO/17 | 13/04/2018 (ex DDG n. 203 del 20/03/2002) | 13/04/2018 | 1.557,38 € | -- | Curriculum | -- |
GS-US-418-3898 | Studi combinati di fase 2b/3, in doppio cieco, randomizzati, controllati con placebo, per la valutazione dell'efficacia e della sicurezza di Filgotinib nell'induzione e nel mantenimento della remissione in soggetti con colite ulcerosa attiva di grado da moderato a severo | 2016-001392-78 | Profit | GILEAD SCIENCE INC. | Gastroenterologia | D'Inca' Renata | 4066/AO/17 | 12/04/2018 (ex DDG n. 203 del 20/03/2002) | 12/04/2018 | 23.920,00 € | 19/12/2019 | Curriculum | -- |
METRO | Mesoglicano (Prisma®) versus placebo nella prevenzione secondaria della trombosi venosa superficiale | 2016-005184-13 | Profit | MEDIOLANUM | Angiologia | Camporese Giuseppe | 4068/AO/17 | 15/03/2018 (ex DDG n. 203 del 20/03/2002) | 15/03/2018 | 700,00 € | -- | Curriculum | -- |
LCZ696B2319 | Multicenter, open-label, study to evaluate safety, tolerability, pharmacokinetics and, pharmacodynamics of LCZ696 followed by a 52-week randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared with enalapril in pediatric patients from1 month to < 18 years of age with heart failure due to systemic left ventricle systolic dysfunction | 2015-004207-22 | Profit | NOVARTIS FARMA | Cardiologia Pediatrica | Milanesi Ornella Dal 01/10/2019 Castaldi Biagio | 4138/AO/17 | 06/03/2018 (ex DDG n. 203 del 20/03/2002) | 06/03/2018 | Parte 1: 25.360,00 € Parte 2: 8.500,00 € | 30/11/2021 | Curriculum | -- |
CLCZ696G2301 | Prospective ARNI versus ACE inhibitor trial to determine superiority in reducing heart failure events after myocardial infarction | 2016-002154-20 | Profit | NOVARTIS PHARMA AG | Cardiologia | Tona Francesco | 4046/AO/17 | 01/03/2018 (ex DDG n. 203 del 20/03/2002) | 01/03/2018 | 4.170,00 € | 01/10/2018 | Curriculum | -- |
LLC1215 | Studio di fase II sulla combinazione di Ofatumumab e Ibrutinib seguita da trapianto allogenico di midollo osseo o mantenimento per pazienti pretrattati ad alto rischio con leucemia linfoide cronica. | 2015-000684-13 | No Profit | Fondazione GIMEMA Onlus | Ematologia | Trentin Livio | 4273/AO/17 | 27/02/2018 (ex DDG n. 203 del 20/03/2002) | 27/02/2018 | 0,00 € | -- | Curriculum | -- |
CQVM149B2303 | Studio multicentrico, randomizzato, in doppio cieco, della durata di 12 settimane per valutare l'efficacia e la sicurezza di QMF149 (150/80 microgrammi) verso MF Twisthaler® (200 microgrammi) in pazienti adulti e adolescenti con asma | 2016-000472-22 | Profit | NOVARTIS PHARMA AG | Pneumologia e Allergologia Pediatrica | Zanconato Stefania | 4110/AO/17 | 02/02/2018 (ex DDG n. 203 del 20/03/2002) | 02/02/2018 | 4.820,00 € | 18/04/2018 | Curriculum | -- |
OMS/DES 2011 | Multinational European Trial for Children with the Opsoclonus Myoclonus Syndrome/Dancing Eye Syndrome. | 2011-000990-20 | No Profit | AIEOP - Assocazione Italiana Ematologia Oncologia Pediatrica | Clinica di Oncoematologia Pediatrica | Viscardi Elisabetta | 3297/AO/14 | 19/09/2014 | 25/01/2018 | 0,00 € | -- | Curriculum | NA Avvio dello studio a seguito del parere favorevole definitivo del CE espresso nella seduta del 25/01/2018 |
ARC010 ARTEMIS | AR101 Trial in Europe Measuring oral Immunotherapy Success in peanut allergic children (ARTEMIS). | 2016-005004-16 | Profit | AIMMUNE THERAPEUTICS Inc | U.O.S.D. Allergie Alimentari | Muraro Maria Antonella | 4230/AO/17 | 15/01/2018 (ex DDG n. 203 del 20/03/2002) | 15/01/2018 | 19.309,56 € | 30/04/2019 | Curriculum | -- |
GBT440-031 | A phase 3 , double-blind, randomized, placebo-controlled, multicenter study of GBT440 administered orally to patients with sickle cell disease | 2016-003370-40 | Profit | Clobal Blood Therapeutics | Clinica di Oncoematologia Pediatrica | Colombatti Raffaella | 4112/AO/17 | 19/12/2017 (ex DDG n. 203 del 20/03/2002) | 19/12/2017 | Gruppo 1: 7.328,00 € Gruppo 2 e 3: 6.607,00 € | 04/09/2019 | Curriculum | -- |
201000 | A randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis. (GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response). | 2016-002416-41 | Profit | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | Gastroenterologia | Floreani Annarosa Dal 01/10/2019 Farinati Fabio | 4146/AO/17 | 19/12/2017 (ex DDG n. 203 del 20/03/2002) | 19/12/2017 | 4.200,00 € | 20/02/2020 | Curriculum | -- |
FADOI_03.2016 | Apixaban per il trattamento del tromboembolismo venoso in pazienti con cancro: studio prospettico, randomizzato, in aperto, con valutazione in cieco degli endpoint (PROBE). Studio CARAVAGGIO | 2016-003093-40 | No Profit | Fondazione FADOI | Clinica Medica 3 | Pesavento Raffaele | 4086/AO/17 | 16/11/2017 (ex DDG n. 203 del 20/03/2002) | 16/11/2017 | 2.500,00 € | -- | Curriculum | -- |
DSE-EDO-01-15-EU | Valutazione della sicurezza e dell'efficacia di un regime antitrombotico basato su edoxaban rispetto ad un regime basato sugli antagonisti della vitamina K a seguito di riuscito intervento coronarico percutaneo (ICP) con inserimento di stent | 2016-002683-14 | Profit | DAIICHI SANKYO EUROPE GMBH | Cardiologia | Tarantini Giuseppe | 4071/AO/17 | 10/11/2017 (ex DDG n. 203 del 20/03/2002) | 10/11/2017 | Paziente Edoxaban: 3.777,00 € Paziente VKA 4.453,00 € | -- | Curriculum | -- |
CML1516 | STUDIO DI EFFICACIA, SICUREZZA E TOLLERABILITA DI BOSUTINIB (BEST) IN PAZIENTI ANZIANI AFFETTI DA LEUCEMIA MIELOIDE CRONICA RESISTENTI AL TRATTAMENTO DI PRIMA LINEA CON ALTRI FARMACI INIBITORI DELLA TIROSIN-CHINASI | 2016-002216-40 | No Profit | Fondazione GIMEMA Onlus | Ematologia | Binotto Gianni | 4135/AO/17 | 10/11/2017 (ex DDG n. 203 del 20/03/2002) | 10/11/2017 | 0,00 € | 22/06/2022 | Curriculum | -- |
Z7224L01 | Studio clinico multicentrico, controllato con placebo, in doppio cieco, per valutare l'efficacia e la sicurezza di 12 mesi di terapia con Promixin? (colistimetato di sodio) per via inalatoria nel trattamento di soggetti con bronchiectasie non da fibrosi cistica con infezione cronica da Pseudomonas aeruginosa (P. aeruginosa) | 2015-002743-33 | Profit | ZAMBON ITALIA | Pneumologia | Saetta Marina | 4100/AO/17 | 10/11/2017 (ex DDG n. 203 del 20/03/2002) | 10/11/2017 | 3.595,00 € | 14/09/2018 | Curriculum | -- |
EFX14336 ICARIA-MM | A phase 3 randomized, open-label, multicenter study comparing Isatuximab (SAR650984) in Combination with pomalidomide And low-dose dexamethasone veRsus pomalidomide and low-dose dexamethasone In patients with refractory or relapsed And refractory Multiple Myeloma | 2016-003097-41 | Profit | SANOFI S.P.A. | Ematologia | Zambello Renato | 4168/AO/17 | 24/10/2017 (ex DDG n. 203 del 20/03/2002) | 24/10/2017 | Braccio sperimentale: 13.200 € Braccio controllo: 7.290,00 € | -- | Curriculum | -- |
CL2-42909-016 | Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer. A 10-week randomized, double-blind, placebo-controlled, prospective, international, multicentre, phase IIa study. | 2016-004143-36 | Profit | INSTITUT DE RECHERCHES INTERNATIONALES SERVIER | Angiologia | Avruscio Giampiero | 4186/AO/17 | 20/10/2017 (ex DDG n. 203 del 20/03/2002) | 20/10/2017 | 5.110,00 € | 24/03/2020 | Curriculum | -- |
LIVERHOPE_SAFETY | Safety and tolerability of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis: a multicenter, double-blind, placebo controlled randomized clinical trial. | 2016-004499-23 | No Profit | AZIENDA OSPEDALIERA DI PADOVA | Clinica Medica 5 | Angeli Paolo | 4169/AO/17 | 20/10/2017 (ex DDG n. 203 del 20/03/2002) | 20/10/2017 | 261,30 € | -- | Curriculum | -- |
-- | Sicurezza e efficacia del trattamento con propranololo 0.2% per uso topico nei neonati affetti da retinopatia del prematuro: studio pilota. | 2014-005472-29 | No Profit | AZIENDA OSPEDALIERA MEYER | Patologia Neonatale | Lago Paola | 4215/AO/17 | 11/10/2017 (ex DDG n. 203 del 20/03/2002) | 11/10/2017 | 0,00 € | 20/04/2018 | Curriculum | -- |
ARC004 PALISADE Follow On | Peanut allergy oral immunotherapy study of AR101 for desensitization in children and adults (PALISADE) follow-on study | 2016-004941-94 | Profit | AIMMUNE THERAPEUTICS Inc | U.O.S.D. Allergie Alimentari | Muraro Maria Antonella | 4117/AO/17 | 20/09/2017 (ex DDG n. 203 del 20/03/2002) | 20/09/2017 | Gruppo 1: 18.108,78 € Gruppo 2 Coorte 1: 2.126,24 € Gruppo 2 Coorte 2: 3.043,65 € Gruppo 2 Coorte 3A: 3.245,39 € Gruppo 2 Coorte 3B: 4.373,05 € Gruppo 2 Coorte 3C: 6.216,89 € | 15/11/2019 | Curriculum | -- |
PEITHO-2 CTH C007 | Safety and Efficacy of Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for the Treatment of Acute Intermediate-Risk Pulmonary Embolism | 2015-001830-12 | Profit | GUTENBERG UNIVERSITY MEDICAL CENTER, DEPT. OF MEDICINE I | Cardiologia | Pengo Vittorio | 4103/AO/17 | 07/09/2017 (ex DDG n. 203 del 20/03/2002) | 07/09/2017 | 1.795,00 € | 31/07/2018 | Curriculum | -- |
COMB157G2302 | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 2015-005419-33 | Profit | NOVARTIS FARMA | Clinica Neurologica | Gallo Paolo | 4116/AO/17 | 31/08/2017 (ex DDG n. 203 del 20/03/2002) | 31/08/2017 | 17.150,00 € | -- | Curriculum | -- |
PROMISE | Protein misfolding, amyotrophic lateral sclerosis and guanabenz: a phase II rct with futility design | 2014-005367-32 | No Profit | ISTITUTO NEUROLOGICO CARLO BESTA | Clinica Neurologica | Sorarù Gianni | 4087/AO/17 | 28/08/2017 (ex DDG n. 203 del 20/03/2002) | 28/08/2017 | 0,00 € | -- | Curriculum | -- |
SIDEROS SNT-III-012 | A phase III double-blind, randomized, placebo-controlled study assessing the efficacy, safety and tolerability of idebenone in patients with duchenne muscular dystrophy receiving glucocorticoid steroids | 2016-000602-10 | Profit | SANTHERA PHARMACEUTICALS (SWITZERLAND) LTD | Clinica Neurologica | Pegoraro Elena | 4024/AO/16 | 19/06/2017 (ex DDG n. 203 del 20/03/2002) | 19/06/2017 | 6.910,00 € | -- | Curriculum | -- |
GED-0301-CD-004 | Studio di estensione di fase 3 con trattamento attivo a lungo termine di mongersen (GED-0301) in soggetti con morbo di Crohn | 2015-001963-37 | Profit | CELGENE CORPORATION | Gastroenterologia | Sturniolo Giacomo Carlo Dal 27/09/2017 D'Incà Renata | 3981/AO/16 | 15/06/2017 (ex DDG n. 203 del 20/03/2002) | 15/06/2017 | 11.500,00 € | 09/11/2017 | Curriculum | -- |
EuroNet-PHL-C2 | Secondo studio clinico condotto da esperti europei nel campo per il trattamento del linfoma di Hodgkin classico nei bambini e negli adolescenti | 2012-004053-88 | No Profit | A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA | Clinica di Oncoematologia Pediatrica | Pillon Marta | 4012/AO/16 | 12/06/2017 (ex DDG n. 203 del 20/03/2002) | 12/06/2017 | 0,00 € | -- | Curriculum | -- |
PCYC-1142 CA | Studio di fase 2 della combinazione ibrutinib-venetoclax in soggetti affetti da leucemia linfatica cronica (LLC) / linfoma linfocitico a piccole cellule (LLPC) naive al trattamento | 2016-002293-12 | Profit | PHARMACYCLICS INC. | Ematologia | Trentin Livio | 4048/AO/17 | 31/05/2017 (ex DDG n. 203 del 20/03/2002) | 31/05/2017 | 14.907,55 € | -- | Curriculum | -- |
NOAH-AFNET 6 | Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes | 2015-003997-33 | No Profit | KOMPETENZNETZ VORHOFFLIMMERN E.V. (AFNET) | Cardiologia | Bertaglia Emanuele | 3951/AO/16 | 25/05/2017 (ex DDG n. 203 del 20/03/2002) | 25/05/2017 | 1.790,00 € | 31/12/2022 | Curriculum | -- |
FIL_BArT | Studio multicentrico per valutare l?attivita antivirale di un trattamento senza interferone con ledipasvir piu sofosbuvir (genotipi 1 e 4) e sofosbuvir piu velpatasvir (genotipi 2 e 3) in pazienti affetti da linfoma indolente a cellule B associato ad infezione da virus dell'epatite C | 2015-004830-81 | No Profit | FONDAZIONE ITALIANA LINFOMI ONLUS | Ematologia | Piazza Francesco | 3991/AO/16 | 03/05/2017 (ex DDG n. 203 del 20/03/2002) | 03/05/2017 | 0,00 € | -- | Curriculum | -- |
GED-0301-CD-002 | Studio multicentrico di fase 3, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di mongersen (ged-0301) per il trattamento di soggetti con malattia di crohn in fase attiva | 2015-001925-18 | Profit | CELGENE CORPORATION | Gastroenterologia | Sturniolo Giacomo Carlo Dal 27/09/2017 D'Incà Renata | 3980/AO/16 | 28/04/2017 (ex DDG n. 203 del 20/03/2002) | 28/04/2017 | 6.707,62 € | 09/11/2017 | Curriculum | -- |
NeoVanc | Multi-centre randomised open label phase IIb study to compare the efficacy, safety and pharmacokinetics (PK) of an optimised dosing to a standard dosing regimen of vancomycin in neonates and infants aged 90 days with late onset bacterial sepsis known or suspected to be caused by Gram-positive microorganisms | 2015-000203-89 | No Profit | FONDAZIONE PENTA ONLUS | Patologia Neonatale | Baraldi Eugenio | 4037/AO/17 | 18/04/2017 (ex DDG n. 203 del 20/03/2002) | 18/04/2017 | 275,00 € | -- | Curriculum | -- |
MA29957 | A phase IIb, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of sildenafil added to pirfenidone in patients with advanced idiopathic pulmonary fibrosis and intermediate or high probability of group 3 pulmonary hypertension. | 2015-005131-40 | Profit | F. HOFFMANN - LA ROCHE LTD. | Pneumologia | Spagnolo Paolo | 4009/AO/16 | 06/04/2017 (ex DDG n. 203 del 20/03/2002) | 06/04/2017 | 6.300,00 € | -- | Curriculum | -- |
GO29665 | A phase I/II, multicenter, open-label, dose-escalation study of the safety and pharmacokinetics of cobimetinib in pediatric and young adult patients with previously treated solid tumors | 2014-004685-25 | Profit | F. HOFFMANN - LA ROCHE LTD. | Clinica di Oncoematologia Pediatrica | Bisogno Gianni | 3881/AO/16 | 27/03/2017 (ex DDG n. 203 del 20/03/2002) | 27/03/2017 | 5.936,00 € | -- | Curriculum | -- |
ADIPOA-2 | A phase IIb, prospective, multicentre, double-blind, triple-arm, randomized versus placebo trial, to assess the efficacy of a single injection of either 2 or 10 x 106 autologous adipose derived mesenchymal stromal cells (ASC) in the treatment of mild to moderate osteoarthritis (OA) of the knee, active and unresponsive to conservative therapy for at least 12 months. | 2015-002125-19 | No Profit | CHRU DE TOURS | Reumatologia | Punzi Leonardo Dal 01/10/2018 Doria Andrea | 3877/AO/16 | 14/03/2017 (ex DDG n. 203 del 20/03/2002) | 14/03/2017 | 3.764,35 € | 20/10/2021 | Curriculum | -- |
CAIN457F2354 | A 52-week, multicenter study to assess the time course of response to secukinumab on joint inflammation using power doppler ultrasonography in patients with active psoriatic arthritis | 2015-002394-38 | Profit | NOVARTIS PHARMA AG | Reumatologia | Ramonda Roberta | 3992/AO/16 | 14/03/2017 (ex DDG n. 203 del 20/03/2002) | 14/03/2017 | 10.687,00 € | -- | Curriculum | -- |