Clinical Trial

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

Study acronym: GIV-IN-PV
Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated March 25, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2023-10-19; most recent amendment 2026-03-24.
Status change: Not Yet Recruiting → Recruiting 2024-03-05
Trial Details
NCT Number NCT06093672
Lead Sponsor Italfarmaco
Collaborators: PPD Development, LP
Conditions Polycythemia Vera
Enrollment 220 participants
Start Date 2024-03-26
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-03-25