ClinicaliQ Trial Snapshot
- Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera — Recruiting • Phase III • Cardiology / Cardiovascular • NCT06093672.
- The goal of this clinical trial is to compare the efficacy and safety of givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera patients. Lead.
- Sponsor: Italfarmaco.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The goal of this clinical trial is to compare the efficacy and safety of givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera patients. Lead Sponsor: Italfarmaco Start Date: 2024-03-26 Primary Completion: 2026-07
Eligibility Snapshot
- Core Treatment - Inclusion Criteria: * Patients must have been diagnosed with PV according to the 2016 WHO criteria before randomization * Patients must have JAK2V617F-positive disease * Patients with PV must meet the definition of HR for thrombosis (i.e., HR) within 3 years before screening as follows: * Age ≥ 60 years, and/or * Prior thrombosis. * Patients must be in need of treatment at screening, defined by the presence of at least one of the following: * HCT ≥ 45% or HCT < 45% with at least 1 phlebotomy performed in the 3 months before screening, or * WBC count > 10 × 109/L, or * PLT count > 400 × 109/L. * Patients must have normalized HCT (i.e., HCT < 45%) at randomization Extended Treatment - Inclusion Criteria * Patients must have completed the Week 48 visit of the DSC/08/2357/32 core treatment phase and: 1. if the patient received givinostat, a complete hematological response (CHR) at Week 48 shall be achieved 2. if the patient received HU, did not achieve a CHR (see above for the definition) at Week 48 Core Treatment phase -
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.