This clinical trial is focused on studying a condition called Polycythemia Vera, which is a type of blood cancer that causes the body to produce too many red blood cells. This can lead to complications such as blood clots. The study is specifically looking at patients who have a mutation known as JAK2V617F-positive and are considered high-risk due to factors like age or previous blood clots. The trial will compare the effectiveness and safety of a medication called Givinostat against another treatment known as Hydroxyurea.

The purpose of the study is to determine which treatment is more effective and safer for patients with high-risk Polycythemia Vera. Participants in the study will receive either Givinostat or Hydroxyurea for a period of 48 weeks. During this time, doctors will monitor the patients to see how well the treatments work in controlling the disease and to check for any side effects. The study will also involve regular check-ups and tests to ensure the safety and well-being of the participants.

Throughout the study, the goal is to see if patients can maintain a healthy level of red blood cells without needing additional procedures like phlebotomy, which is a process to remove blood from the body. The study will also look at other factors such as white blood cell counts, platelet levels, and spleen size, which can be measured using imaging techniques like MRI or CT scans. The results will help determine the best treatment option for managing high-risk Polycythemia Vera.