Study to Assess the Self-administration of AOP2014 Using a Pen, Developed for the Treatment of Polycythemia Vera Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Polycythemia Vera
Interventions
DRUG

Pegylated-Proline-Interferon alpha-2b in a Pre-filled Pen

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.

Trial Locations (35)

Unknown

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

Specialized Hospital for Active Treatment of Hematological Diseases, Sofia

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

University Hospital Brno, Brno

University Hospital Hradec Kralove, Hradec Králové

Institute of Hematology and Blood Transfusion, Prague

University Hospital Kralovske Vinohrady, Prague

University Hospital Motol, Prague

Institute Paoli-Calmettes, Marseille

Hospital Saint-Louis, Paris

Clinical Research Center CIC, Poitiers

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

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

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

University Hospital with Outpatient Clinic F.D. Roosevelt, Banská Bystrica

Saint Cyril and Metod University Hospital Bratislava, Bratislava

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

Sponsors
All Listed Sponsors
collaborator

PharmaEssentia Corporation (Co-Sponsor for USA)

UNKNOWN

lead

AOP Orphan Pharmaceuticals AG

INDUSTRY

NCT02523638 - Study to Assess the Self-administration of AOP2014 Using a Pen, Developed for the Treatment of Polycythemia Vera Patients | Biotech Hunter | Biotech Hunter