7 completed, 4 terminated, 1 active not recruiting, 1 recruiting. 13 Phase 2, 5 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 13 | Completed 7, Terminated 4, Active not recruiting 1, Recruiting 1 |
| Phase 1 | 5 | Completed 3, Terminated 2 |
| Phase 3 | 1 | Recruiting 1 |
Follow givinostat: new trials by email Literature Review of givinostat trials Research Report on givinostat
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy Givinostat, Placebo - Becker Muscular Dystrophy | Phase 2 | Completed | Italfarmaco | 51 | 2018-01-09 | 2024-11-18 |
| Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study Givinostat - Duchenne Muscular Dystrophy | Phase 2 / Phase 3 | Recruiting | Italfarmaco | 206 | 2017-10-24 | 2026-01-21 |
| A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera Givinostat - Polycythemia Vera | Phase 1 / Phase 2 | Completed | Italfarmaco | 48 | 2013-10-01 | 2019-07-30 |
| A Study to Assess Safety/Tolerability, pk, Effects on Histology, Clinical Parameters of Givinostat in Children With DMD Givinostat - Duchenne Muscular Dystrophy (DMD) | Phase 1 / Phase 2 | Completed | Italfarmaco | 20 | 2013-04-01 | 2023-11-07 |
| Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms givinostat - Chronic Myeloproliferative Neoplasms | Phase 2 | Active not recruiting | Italfarmaco | 90 | 2013-03-01 | 2025-04-30 |
| Efficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic Arthritis Givinostat - Polyarticular Course Juvenile Idiopathic Arthritis | Phase 2 | Terminated | Italfarmaco | 16 | 2010-10-01 | 2014-04-16 |
| Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea, GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea - Polycythemia Vera | Phase 2 | Completed | Italfarmaco | 45 | 2009-06-01 | 2019-10-31 |
| Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia ITF2357 - Chronic Lymphocytic Leukemia | Phase 2 | Terminated | Italfarmaco | 3 | 2008-02-01 | 2022-01-27 |
| Trial of the Histone-Deacetylase Inhibitor ITF2357 Followed by Mechlorethamine in Relapsed/Refractory Hodgkin's Lymphoma ITF2357 - Hodgkin's Lymphoma | Phase 1 / Phase 2 | Completed | Italfarmaco | 24 | 2008-02-01 | 2021-05-11 |
| Phase IIA Study of the HDAC Inhibitor ITF2357 in Patients With JAK-2 V617F Positive Chronic Myeloproliferative Diseases ITF2357 - Myeloproliferative Diseases | Phase 2 | Completed | Italfarmaco | 29 | 2007-12-01 | 2019-12-03 |
| Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease ITF2357, Placebo - Crohn's Disease | Phase 1 / Phase 2 | Terminated | Italfarmaco | 51 | 2007-10-22 | 2023-07-19 |
| phII Study of an HDAC Inhibitor in Very High-risk Relapsed/Refractory Hodgkin's Lymphoma Patients histone deacetylase inhibitor (ITF2357) - Hodgkin's Lymphoma | Phase 1 / Phase 2 | Terminated | Italfarmaco | 19 | 2007-05-01 | 2022-01-27 |
| Open Label, Multicentre Trial to Assess Safety and Efficacy of ITF2357 in Active Systemic Juvenile Idiopathic Arthritis ITF2357 - Active Systemic, Onset Juvenile Idiopathic Arthritis | Phase 2 | Completed | Italfarmaco | 17 | 2006-09-12 | 2021-05-04 |
Polycythemia Vera (4) · Muscular Dystrophy, Duchenne (3) · Primary Myelofibrosis (3) · Thrombocythemia, Essential (3) · Hodgkin Disease (2) · Myeloproliferative Disorders (2) · Arthritis, Juvenile (1) · Crohn Disease (1) · Leukemia, Lymphocytic, Chronic, B-Cell (1) · Rare Diseases (1)
Italfarmaco (13)
Italy (12) · Belgium (3) · Germany (3) · Netherlands (3) · Serbia (3) · United Kingdom (3) · France (2) · Romania (2) · Spain (2) · Canada (1) · Czechia (1) · Israel (1) · Poland (1) · Slovenia (1) · United States (1)
Alessandro Rambaldi, MD (3) · Alessandro Massimo Gianni, MD (2) · Enrico Bertini, MD (1) · Francesco Zulian, MD (1) · Giacomo Comi, MD (1) · Massimo Martelli, MD (1) · Nemanja Damjanov, MD, PhD (1) · Paolo Bettica, MD (1) · Paul Rutgeerts, MD (1)
PMID 21308151, PMID 21538322, PMID 27566866, PMID 40830818
2017 (1)