The GIV-IN PV TRIAL
Research type
Research Study
Full title
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
IRAS ID
1007039
Contact name
Lucia Zanetta
Contact email
Sponsor organisation
Italfarmaco S.p.A.
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to learn how well a new drug called Givinostat works to treat Polycythemia Vera (PV) and what side effects patients have when they take it. PV is a rare form of cancer in which the body makes too many blood cells. Without treatment, PV can be life threatening, however proper medical care can help ease the symptoms and complications of this disease.
There are approved medicines available for the treatment of PV. One of the widely used medicines to treat PV is Hydroxyurea.
The goal of this study is to check whether treatment with Givinostat is better for the treatment of PV as compared to Hydroxyurea and whether patients are benefiting from the treatment and how long their PV symptoms continue to get better. Other goals are to learn more about Givinostat side effects and if the treatment improves quality of life.
Patients will be selected by chance to receive Givinostat (new study drug) or the Hydroxyurea (comparator drug).
Study visits will be around every month for up to 52 weeks (not including the screening phase) and patients will have to visit the hospital approximately 15 times.
Study procedures include physical examination, vital signs, blood and urine sampling, phlebotomy (removal of a certain amount of blood) to keep blood levels in a safe range, Electrocardiogram (ECG), bone marrow biopsy, spleen imaging and questionnaires.
This study is sponsored by Italfarmaco S.p.A.
Participation in this study is completely voluntary.REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0950
Date of REC Opinion
12 Jan 2024
REC opinion
Further Information Favourable Opinion