Givinostat

DRUG12 trials

Sponsors

Italfarmaco

Conditions

Becker Muscular DystrophyChronic Myeloproliferative NeoplasmsDrug Drug InteractionDuchenne Muscular DystrophyDuchenne Muscular Dystrophy (DMD)Juvenile Idiopathic ArthritisPolyarticular Course Juvenile Idiopathic ArthritisPolycythemia Vera

Phase 1

A Study to Assess Safety/Tolerability, pk, Effects on Histology, Clinical Parameters of Givinostat in Children With DMD

CompletedNCT01761292

ItalfarmacoDuchenne Muscular Dystrophy (DMD)

Start: 2013-04-30End: 2017-11-30Updated: 2023-11-07

A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera

CompletedNCT01901432

ItalfarmacoPolycythemia Vera

Start: 2013-10-31End: 2017-09-25Updated: 2019-07-30

The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)

CompletedNCT05845567

ItalfarmacoDrug Drug Interaction

Start: 2022-03-21End: 2022-05-24Updated: 2024-08-16

Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3)

CompletedNCT05860114

ItalfarmacoDrug Drug Interaction

Start: 2022-03-21End: 2022-05-24Updated: 2025-01-24

Phase 2

Efficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic Arthritis

TerminatedNCT01261624

ItalfarmacoPolyarticular Course Juvenile Idiopathic Arthritis

Start: 2010-10-31End: 2013-03-31Updated: 2014-04-16

Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms

Active, not recruitingNCT01761968

ItalfarmacoChronic Myeloproliferative Neoplasms

Start: 2013-03-31End: 2026-12-31Target: 90Updated: 2025-04-30

Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy

CompletedNCT03238235

ItalfarmacoBecker Muscular Dystrophy

Start: 2018-01-09End: 2021-03-19Updated: 2024-11-18

Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study

RecruitingNCT03373968

ItalfarmacoDuchenne Muscular Dystrophy

Start: 2017-10-24End: 2029-12-01Target: 206Updated: 2026-01-21

Phase 3

Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy

CompletedNCT02851797

ItalfarmacoDuchenne Muscular Dystrophy

Start: 2017-06-06End: 2022-02-22Updated: 2023-02-02

Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy

RecruitingNCT05933057

ItalfarmacoDuchenne Muscular Dystrophy

Start: 2024-02-19End: 2028-02-01Target: 138Updated: 2026-07-24

Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera

RecruitingNCT06093672

ItalfarmacoPolycythemia Vera

Start: 2024-03-26End: 2026-07-01Target: 220Updated: 2026-03-25

Unknown Phase

Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis

TerminatedNCT01557452

ItalfarmacoJuvenile Idiopathic Arthritis

Start: 2011-12-28End: 2014-01-27Updated: 2021-04-06

Related Papers

Using a medically trained LLM-based end-to-end system in automating patient eligibility screening across a health system for A phase 3 study evaluating the safety of givinostat in patients with polycythemia vera.

Blood2025-11-03

Trial in progress: Efficacy and safety of givinostat versus hydroxyurea in patients with polycythemia vera (GIV-IN-PV)

Blood2025-11-03

Long‐Term Evaluation of Givinostat in Duchenne Muscular Dystrophy, and Natural History Comparisons

Annals of Clinical and Translational Neurology2025-08-193 citations

Safety and efficacy of givinostat in boys with Duchenne muscular dystrophy (EPIDYS): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

2024-04-0180 citations

A Two-Part Study of Givinostat in Patients with Polycythemia Vera: Maximum Tolerated Dose Definition and Preliminary Efficacy Results

Blood2016-12-027 citations