πŸ›οΈ Verified NIH Record β€’ Updated 2026-03-24

Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera (NCT06093672)

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

🟒 Recruiting Phase3 πŸ’Š Investigational Drug / Biologic Sponsor: Italfarmaco

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham β€” Birmingham, Alabama

Age range: 18 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (90 Sites)

Showing the first 25 of 90 sites.

  • University of Alabama at Birmingham β€” Birmingham, Alabama
  • Emad Ibrahim, MD, Inc β€” Redlands, California
  • US Oncology Inc β€” Englewood, Colorado
  • American Oncology Partners of Maryland, PA β€” Bethesda, Maryland
  • Icahn School of Medicine at Mount Sinai β€” New York, New York
  • University of North Carolina at Chapel Hill β€” Chapel Hill, North Carolina
  • The Cleveland Clinic Foundation β€” Cleveland, Ohio
  • Oncology Associates of Oregon, P.C. β€” Eugene, Oregon
  • MD Anderson Cancer Center β€” Houston, Texas
  • Texas Oncology (Webster) - USOR β€” Houston, Texas
  • Texas Oncology-Denison Cancer Center β€” Sherman, Texas
  • University of Utah - Huntsman Cancer Institute - PPDS β€” Salt Lake City, Utah
  • The James Cancer Hospital and Solove Research Institute β€” Roanoke, Virginia
  • VA Puget Sound Health Care System - NAVREF - PPDS β€” Seattle, Washington
  • Landesklinikum Wiener Neustadt β€” Wiener Neustadt, Lower Austria
  • Medizinische Universitat Wien (Medical University of Vienna) β€” Vienna, State of Vienna
  • Ordensklinikum Linz GmbH Elisabethinen β€” Linz, Upper Austria
  • Klinikum Wels-Grieskirchen GmbH β€” Wels, Upper Austria
  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda β€” Sofia, Sofia-Grad
  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD β€” Plovdiv,
  • University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD β€” Stara Zagora,
  • Clinical Hospital Dubrava β€” Zagreb, City of Zagreb
  • Clinical Hospital Center Rijeka - PPDS β€” Rijeka,
  • Clinical Hospital Center Rijeka β€” Rijeka,
  • General Hospital Sibenik β€” Ε ibenik,

πŸ“ž Contact the Study Coordinator

Phone: +39 02 6443 1

Email: patientadvocacy@italfarmacogroup.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—