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

Source: https://onco.cc/trials/nct06093672/  
OnCo record `nct06093672` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing Givinostat in myeloproliferative neoplasms, now recruiting.

## Summary

Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera is a phase 3 interventional study registered as NCT06093672, led by Italfarmaco with PPD Development, LP, and recruiting on the registry. Official title: Randomised, Open-label, Multicenter Phase 3 Study to Assess the Efficacy and Safety of GIVinostat Versus Hydroxyurea IN JAK2V617F-positive High-risk Polycythemia Vera Patients: the GIV-IN PV TRIAL. Planned enrolment is 220 participants (estimated). The study started in 2024-03-26 and primary completion is expected in 2026-07. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: NCT06093672
- Phase: 3
- Setting: Randomized, Open-label, Multicenter Phase 3 Study to Assess the Efficacy and Safety of GIVinostat Versus Hydroxyurea IN JAK2V617F-positive High-risk Polycythemia Vera Patients: the GIV-IN PV TRIAL
- Sponsor: Italfarmaco
- Enrolled: 220

## Sources

- ClinicalTrials.gov NCT06093672: https://clinicaltrials.gov/study/NCT06093672

## Connected records

- cancers: [Myeloproliferative neoplasms (PV, ET, myelofibrosis)](https://onco.cc/cancers/myeloproliferative-neoplasms/), [Polycythaemia vera (PV)](https://onco.cc/cancers/polycythaemia-vera/)
- drugs: [Givinostat](https://onco.cc/drugs/givinostat/)
- companies: [Italfarmaco](https://onco.cc/companies/italfarmaco/)

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