NCT06093672 · Italfarmaco
Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
(GIV-IN-PV)
What this study is about
The goal of this clinical trial is to compare the effectiveness and safety of givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera patients.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must have been diagnosed with PV according to the 2016 WHO criteria before randomization
- Patients must have JAK2V617F-positive disease
- Patients with PV must meet the definition of HR for thrombosis (i.e., HR) within 3 years before screening as follows:
- Age ≥ 60 years, and/or
- Prior thrombosis.
- Patients must be in need of treatment at screening, defined by the presence of at least one of the following:
- HCT ≥ 45% or HCT \< 45% with at least 1 phlebotomy performed in the 3 months before screening, or
- WBC count \> 10 × 109/L, or
- PLT count \> 400 × 109/L.
- Patients must have normalized HCT (i.e., HCT \< 45%) at randomization Extended Treatment - Inclusion Criteria
- Patients must have completed the Week 48 visit of the DSC/08/2357/32 core treatment phase and: 1. if the patient received givinostat, a complete hematological response (CHR) at Week 48 shall be achieved 2. if the patient received HU, did not achi
Where
- Birmingham, Alabama
- Redlands, California
- Englewood, Colorado
- Bethesda, Maryland
- New York, New York
- Chapel Hill, North Carolina
- Cleveland, Ohio
- Eugene, Oregon
- Houston, Texas
- Sherman, Texas
- Salt Lake City, Utah
- Roanoke, Virginia
And 1 more location — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 25, 2026 · Source of record for eligibility and locations