8 completed, 2 terminated. 10 Phase 1, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 8, Terminated 2 |
| Phase 2 | 5 | Completed 3, Terminated 2 |
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 |
|---|---|---|---|---|---|---|
| Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function ITF2357 - Hepatic Impairment | Phase 1 | Completed | Italfarmaco | 24 | 2025-05-29 | 2026-06-18 |
| Perpetrator DDI Potential of Givinostat as Inhibitor and Inducer of CYP3A and P-gp Activity Givinostat 10 mg/mL, Midazolam 1mg/ml IV, Midazolam 2.5 mg oromucosal solution - Drug-Drug Interaction, Heathy Volunteer | Phase 1 | Completed | Italfarmaco | 26 | 2022-03-21 | 2025-01-06 |
| Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3) Givinostat - Drug Drug Interaction | Phase 1 | Completed | Italfarmaco | 8 | 2022-03-21 | 2025-01-24 |
| The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2) Givinostat, Clarithromycin - Drug Drug Interaction | Phase 1 | Completed | Italfarmaco | 20 | 2022-03-21 | 2024-08-16 |
| Placebo-Corrected Effects of Therapeutic Dose (100 mg) and Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval ITF2357 10 mg/mL, Placebo, Moxifloxacin Hydrochloride - Duchenne and Becker Muscular Dystrophy, Polycytemia Vera | Phase 1 | Completed | Italfarmaco | 31 | 2021-04-13 | 2024-01-11 |
| 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 |
| 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 |
| 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 |
Hodgkin Disease (2) · Muscular Dystrophy, Duchenne (2) · Crohn Disease (1) · Myeloproliferative Disorders (1) · Polycythemia Vera (1) · Primary Myelofibrosis (1) · Rare Diseases (1) · Thrombocythemia, Essential (1)
Italfarmaco (10)
Italy (5) · Portugal (3) · France (2) · Belgium (1) · Bulgaria (1) · Canada (1) · Germany (1) · Netherlands (1) · Poland (1) · United Kingdom (1)
Marlene Fonseca, MD (3) · Alessandro Massimo Gianni, MD (2) · Enrico Bertini, MD (1) · Paolo Bettica, MD (1) · Paul Rutgeerts, MD (1)