Polycythemia Vera: Givinostat vs. Hydroxyurea

We are studying a new treatment called Givinostat for patients with high-risk Polycythemia Vera to see if it works better and is safer than the standard medication, hydroxyurea.

1-2 years 11-15 visits Confirmation phase (III)Post-Trial Drug Access No Placebo Cost Reimbursement Investigational Medicines Oral InjectionHematologyInternal Medicine

What diseases are being studied?

Health conditions and diseases that the clinical trial is designed to study and treat.

Who can participate in the clinical trial?

These questions help us understand your situation so we can let the trial team know whether you might be a potential match. This is not a medical evaluation and is not part of the official screening, the study doctor will make the final decision..

What medicines are being studied?

Medicines that are officially approved for use in the European Union and considered safe by EMA. These medicines are already on the market and may be tested for new conditions or populations.

Dabigatran Etexilate

Dabigatran etexilate is a medicine used to prevent and treat blood clots and lower the risk of stroke.

Enoxaparin Rovi

Enoxaparin Rovi is an injectable blood-thinning medicine used to prevent and treat dangerous blood clots.

What active substances are being studied?

Active substances that are officially approved for use in the European Union and considered safe by EMA. These substances are already on the market and may be tested for new conditions or populations.

Acetylsalicylic Acid

Acetylsalicylic acid is a substance that reduces pain, fever, and inflammation and can help prevent blood clots.

Carbasalate Calcium

Carbasalate calcium is a substance that reduces pain and fever and helps prevent blood clots by stopping platelets from clumping.

Dabigatran Etexilate

Dabigatran etexilate is a blood thinner that prevents and treats harmful blood clots and lowers stroke risk in people with irregular heartbeat.

What experimental substances are being tested?

Experimental substances that are being investigated in this clinical trial. These are not yet approved for general use.

Givinostat

What similar medicines might you know?

Don't worry if you don't know the medicines tested in the trial. There is a chance you have heard about the similar medicines. Check the list below to see if you are familiar with any of them.

Abagat

Andabra

Arovi

Where is the clinical trial being conducted?

Locations and medical facilities where this clinical trial is currently recruiting or conducting research. Select the locations where you would like to participate.

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Ordensklinikum Linz GmbH

Department of Hematology with stem cell transplantation, hemostaseology and medical oncology

Linz, Austria

Medical University Of Vienna

Department of Medicine I, Division of Hematology and Hemostaseology

Vienna, Austria

Klinikum Wels-Grieskirchen GmbH

Department of internal medicine IV

Wels, Austria

Sponsor: Italfarmaco S.p.A.

Last updated: Nov 27, 2025

Disclaimer: Parts of this content have been automatically extracted from the EU Clinical Trials registry. While we strive for accuracy, please always contact the trial site or sponsor directly for correct and official information before making any decisions about participation. View on EU Clinical Trials.