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

NCT06093672 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Givinostat

Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.

DRUG

Hydroxyurea

Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Italfarmaco

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-26
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Bulgaria
  • Croatia
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Serbia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06093672 on ClinicalTrials.gov