170
Participants
Start Date
November 30, 2014
Primary Completion Date
April 29, 2021
Study Completion Date
April 29, 2021
Pegylated-Proline-interferon alpha-2b
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.
Best available therapy (BAT)
Best available therapy as selected by the investigator
LKH Graz, Graz
University Hospital Innsbruck, Innsbruck
Elisabethinen Hospital Linz, Linz
Salzburg Regional Hospital, Salzburg
Hanusch Hospital, Vienna
Medical University Vienna, Vienna
Hospital Wels-Grieskirchen, Wels
"University Multiprofile Hospital for Active Treatment Sveti Georgi, Plovdiv", Plovdiv
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia
"Multiprofile Hospital for Active Treatment Sveta Marina, Varna", Varna
Multiprofile Hospital for Active Treatment - Hristo Botev, Vratsa, First Department of Internal Medicine, Vratsa
University Hospital Brno, Brno
University Hospital Hradec Kralove, Hradec Králové
University Hospital Kralovske Vinohrady, Prague
University Hospital Motol, Prague
Institute Paoli-Calmettes, Marseille
Hospital Saint-Louis, Paris
Clinical Research Center CIC, Poitiers
Aachen University Hospital, Medical Clinic IV, Aachen
University Hospital Bonn, Center for Internal Medicine, Medical Clinic and Outpatient Clinic III, Bonn
University Hospital Carl Gustav Carus, Medical Clinic and Polyclinic I, Dresden
St Istvan and St Laszlo Hospital of Budapest, Budapest
University of Debrecen, Debrecen
Bekes County Pandy Kalman Hospital, 1st Department of Medicine, Hematology, Gyula
Kaposi Mor County Teaching Hospital, Kaposvár
University of Szeged, Albert Szent-Gyorgyi Clinical Center, Koranyi fasor 6, Szeged
University Hospital in Cracow, Krakow
Independent Public Teaching Hospital No.1 in Lublin, Lublin
Fryderyk Chopin Provincial Specialized Hospital, Rzeszów
Nicolaus Copernicus Municipal Specialist Hospital, Torun
Institute of Hematology and Transfusion Medicine, Warsaw
Emergency Clinical County Hospital Brasov, Brasov
Bucharest University Emergency Hospital, Bucharest
Coltea Clinical Hospital, Bucharest
Baranov Republican Hospital, Petrozavodsk
Samara Kalinin Regional Clinical Hospital, Samara
Komi Republican Oncology Center, Syktyvkar
Tula Regional Clinical Hospital, Tula
Yaroslavl Regional Clinical Hospital, Yaroslavl
University Hospital with Outpatient Clinic F.D. Roosevelt, Banská Bystrica
Saint Cyril and Metod University Hospital Bratislava, Bratislava
Hospital del Mar, Barcelona
Cherkasy Regional Oncology Center, Regional Treatment and Diagnostics Hematology Center, Cherkasy
Dnipropetrovsk City Multispecialty Clinical Hospital #4, Dnipropetrovsk
National Research Center for Radiation Medicine, Institute of Clinical Radiology, Kiev
Institute of Blood Pathology and Transfusion Medicine, Lviv
O.F. Herbachevskyi Regional Clinical Hospital, Zhytomyr
Lead Sponsor
PharmaEssentia Corporation (for the U.S.)
UNKNOWN
AOP Orphan Pharmaceuticals AG
INDUSTRY