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NCT06093672 · ClinicalTrials.gov registry record · Phase 3
Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
A Phase 3 study of Polycythemia Vera, sponsored by Italfarma.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
- 20
- Study locations
NCT06093672: Recruiting Phase 3 study of Polycythemia Vera, sponsored by Italfarma.
NCT06093672 is a Phase 3 study of Polycythemia Vera that is actively recruiting participants, run by Italfarma. The registered enrollment target is 220 participants, below the 330-participant average among 22 other Polycythemia Vera trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06093672, a Phase 3 study of Polycythemia Vera, is actively recruiting participants, sponsored by Italfarma.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Response assessment based on: * Hematocrit \< 45% without phlebotomy in the prior 3 months, and * White blood cell (WBC) count ≤ 10 × 109/L, and * Platelet count ≤ 400 × 109/L, and * Normal spleen size as measured by imaging (normal spleen size is defined as: a longitudinal diameter ≤ 12 cm for female and ≤ 13 cm for male) and * During Part 2 (Week 25 to 48), absence of progressive disease, major hemorrhagic events and major thrombotic events.
Conditions Studied
Interventions
- DRUG Hydroxyurea
- DRUG Givinostat
Study Locations (20)
Texas
- MD Anderson Cancer Center - Houston
- Texas Oncology (Webster) - USOR - Houston
- Texas Oncology-Denison Cancer Center - Sherman
Upper Austria
- Ordensklinikum Linz GmbH Elisabethinen - Linz
- Klinikum Wels-Grieskirchen GmbH - Wels
Alabama
- University of Alabama at Birmingham - Birmingham
California
- Emad Ibrahim, MD, Inc - Redlands
Colorado
- US Oncology Inc - Englewood
Maryland
- American Oncology Partners of Maryland, PA - Bethesda
New York
- Icahn School of Medicine at Mount Sinai - New York
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2024-03-26 |
| Est. Completion | 2026-07 |
| Phase | Phase 3 |
What NCT06093672 shows while recruiting
NCT06093672 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 330-participant average among 22 other Polycythemia Vera trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Polycythemia Vera appearing as the primary indexed condition, and to 2 interventions - of which Hydroxyurea is the first listed.
NCT06093672 names 20 study sites across 17 states, led by Texas, Upper Austria, Alabama.
Frequently Asked Questions
What is clinical trial NCT06093672 about?
NCT06093672 is a clinical study titled "Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera". 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.
What is the current status of trial NCT06093672?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2024-03-26. Estimated completion is 2026-07.
What conditions does trial NCT06093672 study?
This clinical trial studies the following conditions: Polycythemia Vera.
What interventions are being tested in trial NCT06093672?
The interventions under investigation include: Hydroxyurea (DRUG), Givinostat (DRUG).
Who is sponsoring clinical trial NCT06093672?
This trial is sponsored by Italfarma, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06093672 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Polycythemia Vera
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06093672's enrollment target sits among peer trials
220 5th of 22 higher than 18 of 22 other Polycythemia Vera trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Polycythemia Vera trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)
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