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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 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.

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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.

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

FieldValue
Enrollment Target 220 participants
Start Date 2024-03-26
Est. Completion 2026-07
Phase Phase 3

Sponsor

Italfarma

2 total trials

What the Registry Record Tells You About NCT06093672

The ClinicalTrials.gov registry entry for NCT06093672 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 330-participant average among 22 other Polycythemia Vera trials with a reported enrollment target (33% lower). The listed sponsor is Italfarma, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 17 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.