The "GIV-IN PV - New therapeutic approach to Polycythemia Vera" Trial
"Funded as part of the Union's response to the COVID-19 pandemic"
Official 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.
Objectives: The aim of the Project is to evaluate the effectiveness of givinostat compared to hydroxyurea (HU) in controlling the disease in patients affected by polycythemia vera (PV), with high risk for thrombosis. Further objectives of the study will be the evaluation of the safety and tolerability of the drug.
Location: Europe (Austria, Bulgaria, Croatia, France, Germany, Ireland, Spain, Serbia, Hungary), Israel, North America (Canada, USA), United Kingdom.
Co-financed under the National Operational Program for Enterprise and Competitiveness 2014-2020 (PON IC) – Axis VI REACT EU – call for Innovation Agreements