Best available therapy, as chosen by the investigator for patients who had been on HU in the 1 Year PROUD-PV study

AOP2014 for those patients who had been on AOP2014 in the PROUD-PV study

Polycythemia Vera

Subjects will continue to receive the dosage which delivers the optimal disease response (hematocrit [Hct]<45%, platelets [PLTs]<400 x 109/L and leukocytes [WBCs]<10 x 109/L), as determined in the PROUD-PV study, preferably at the level of target blood values.

Pegylated-Proline-interferon alpha-2b

Best available therapy as selected by the investigator

Best available therapy (BAT)

LKH Graz

University Hospital Innsbruck

Elisabethinen Hospital Linz

Salzburg Regional Hospital

Hanusch Hospital

Medical University Vienna

Hospital Wels-Grieskirchen

University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv

Specialized Hospital for Active Treatment of Hematological Diseases

Multiprofile Hospital for Active Treatment "Sveta Marina", Varna

Multiprofile Hospital for Active Treatment - Hristo Botev, Vratsa, First Department of Internal Medicine

University Hospital Brno

University Hospital Hradec Kralove

University Hospital Kralovske Vinohrady

University Hospital Motol

Institute Paoli-Calmettes

Hospital Saint-Louis

Clinical Research Center CIC

Aachen University Hospital, Medical Clinic IV

University Hospital Bonn, Center for Internal Medicine, Medical Clinic and Outpatient Clinic III

University Hospital Carl Gustav Carus, Medical Clinic and Polyclinic I

St Istvan and St Laszlo Hospital of Budapest

University of Debrecen

Bekes County Pandy Kalman Hospital, 1st Department of Medicine, Hematology

Kaposi Mor County Teaching Hospital

University of Szeged, Albert Szent-Gyorgyi Clinical Center, Koranyi fasor 6

University Hospital in Cracow

Independent Public Teaching Hospital No.1 in Lublin

Fryderyk Chopin Provincial Specialized Hospital

Nicolaus Copernicus Municipal Specialist Hospital

Institute of Hematology and Transfusion Medicine

Emergency Clinical County Hospital Brasov

Bucharest University Emergency Hospital

Coltea Clinical Hospital

Baranov Republican Hospital

Samara Kalinin Regional Clinical Hospital

Komi Republican Oncology Center

Tula Regional Clinical Hospital

Yaroslavl Regional Clinical Hospital

University Hospital with Outpatient Clinic F.D. Roosevelt

Saint Cyril and Metod University Hospital Bratislava

Hospital del Mar

Cherkasy Regional Oncology Center, Regional Treatment and Diagnostics Hematology Center

Dnipropetrovsk City Multispecialty Clinical Hospital #4

National Research Center for Radiation Medicine, Institute of Clinical Radiology

Institute of Blood Pathology and Transfusion Medicine

O.F. Herbachevskyi Regional Clinical Hospital

AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study.

An Open-label, Multicenter, Phase IIIb Study Assessing the Long-term Efficacy and Safety of AOP2014 and Standard First Line Treatment (BAT) in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study

The primary efficacy endpoint will be the rate of disease response at assessment visits (every 3 months).
The co-primary efficacy evaluation criterion will be (1) disease response defined as hematologic response: Hct<45% without phlebotomy (at least 3 months since the last phlebotomy), PLTs<400 x 109/L, WBCs<10 x 109/L, and normal spleen size, and (2) disease response defined as hematologic response (Hct<45% without phlebotomy (at least 3 months since the last phlebotomy), PLTs<400 x 109/L, WBCs<10 x 109/L), resolution and/or clinically improvement of disease-related signs (clinical significant splenomegaly) and disease-related symptoms (microvascular disturbances, pruritus, headache).

AOP Orphan Pharmaceuticals AG

PharmaEssentia (Co-Sponsor for USA)

Hydroxyurea capsules (500 mg each). Daily intake of doses from 500 mg Q2D to 3000 mg QD

Peg-P-IFN-alpha-2b at 50mcg to max 500 mcg, given every other week as one subcutanous injection

Pegylated interferon alpha 2b given Q2W as SC injection

Peg-P-IFN-alpha-2b (AOP2014)

Hydroxyurea

Centre du Cancer et D'hematologie

UZA, Antwerp University Hospital

UZ Leuven

Haematolgy, University of Liège

University Multiprofile Hospital for Active Treatment "Sveti Georgi"

Multiprofile Hospital for Active Treatment "Sveta Marina"

Institute of Hematology and Blood Transfusion

Careggi University Hospital

Foundation IRCCS Policlinico San Matteo

Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice

"Prof. Dr. Ion Chiricuta" Institute of Oncology

First Pavlov State Medical University of St. Petersburg

Hospital Clinic i Provincial de Barcelona

Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera

A Randomized, Open-label, Multicenter, Controlled, Parallel Arm, Phase III Study Assessing the Efficacy and Safety of AOP2014 vs. Hydroxyurea in Patients With Polycythemia Vera

Disease response rate is defined as hematocrit <45% without phlebotomy (at least 3 months since last phlebotomy), platelets <400 G/L, leukocytes <10 G/L , and normal spleen size

will be measured during the study period of 12 months

from the first documented response on study

both centrally (blinded assessment) and locally

polycythemia vera

dl prolin

proline

polycythemia vera/dl prolin

AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study.

Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera

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