Spots Global Cancer Trial Database for AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study.
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study.
Official Title: 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
Study ID: NCT02218047
Conditions
Study Description
Brief Summary: Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic increase of red blood cells and frequently also of white blood cells. The "thickening" of the blood in relation with a modified function of the cells has several consequences like increased blood pressure, pruritus of the skin, fatigue, disturbed blood circulation in the brain as well as fingers and toes and an increased risk of arterial and venous thrombosis (thrombosis is the formation of a blood clot in a vessel); like stroke, cardiac infarction, deep vein thrombosis in the legs. In case of a strong increase of platelets there is an additional risk of bleedings. As the disease progresses the size of spleen and liver increased in most cases and the bone marrow shows signs of fibrosis. In some cases of PV a progression at a later time point to a leukemia (increased formation of white blood cells) can occur. The aim of this study is to show that the study drug AOP2014 (pegylated proline interferon alpha-2b) has the long term efficacy and safety in controlling the disease. A comparison arm is receiving best available therapy as selected by the investigator. Response to the treatment is measured by several blood parameters as well as size of the spleen. Interferon-alpha has been shown to be effective in controlling the blood parameters by immunologically influencing the blood building cells. This can lead to a suppression of the disease-causing stem cells and help healthy stem cells to proliferate. Through this mechanism it is possible that Interferon-alpha can avoid long-term damaging effects of the disease.
Detailed Description: This is a Phase III, parallel-arm, open-label continuation of the PROUD-PV study performed in adults diagnosed with Polycythemia Vera (PV). Patients who received AOP2014 in the primary study, PROUD-PV will continue on AOP2014, patients who received HU in the PROUD-PV study will receive best available therapy as selected by the investigator. Only patients who completed PROUD-PV including the end of study visit will be enrolled into this continuation study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
LKH Graz, Graz, , Austria
University Hospital Innsbruck, Innsbruck, , Austria
Elisabethinen Hospital Linz, Linz, , Austria
Salzburg Regional Hospital, Salzburg, , Austria
Hanusch Hospital, Vienna, , Austria
Medical University Vienna, Vienna, , Austria
Hospital Wels-Grieskirchen, Wels, , Austria
University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Plovdiv, , Bulgaria
Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, Varna, , Bulgaria
Multiprofile Hospital for Active Treatment - Hristo Botev, Vratsa, First Department of Internal Medicine, Vratsa, , Bulgaria
University Hospital Brno, Brno, , Czechia
University Hospital Hradec Kralove, Hradec Kralove, , Czechia
University Hospital Kralovske Vinohrady, Prague, , Czechia
University Hospital Motol, Prague, , Czechia
Institute Paoli-Calmettes, Marseille, , France
Hospital Saint-Louis, Paris, , France
Clinical Research Center CIC, Poitiers, , France
Aachen University Hospital, Medical Clinic IV, Aachen, , Germany
University Hospital Bonn, Center for Internal Medicine, Medical Clinic and Outpatient Clinic III, Bonn, , Germany
University Hospital Carl Gustav Carus, Medical Clinic and Polyclinic I, Dresden, , Germany
St Istvan and St Laszlo Hospital of Budapest, Budapest, , Hungary
University of Debrecen, Debrecen, , Hungary
Bekes County Pandy Kalman Hospital, 1st Department of Medicine, Hematology, Gyula, , Hungary
Kaposi Mor County Teaching Hospital, Kaposvar, , Hungary
University of Szeged, Albert Szent-Gyorgyi Clinical Center, Koranyi fasor 6, Szeged, , Hungary
University Hospital in Cracow, Krakow, , Poland
Independent Public Teaching Hospital No.1 in Lublin, Lublin, , Poland
Fryderyk Chopin Provincial Specialized Hospital, Rzeszow, , Poland
Nicolaus Copernicus Municipal Specialist Hospital, Torun, , Poland
Institute of Hematology and Transfusion Medicine, Warsaw, , Poland
Emergency Clinical County Hospital Brasov, Brasov, , Romania
Bucharest University Emergency Hospital, Bucharest, , Romania
Coltea Clinical Hospital, Bucharest, , Romania
Baranov Republican Hospital, Petrozavodsk, , Russian Federation
Samara Kalinin Regional Clinical Hospital, Samara, , Russian Federation
Komi Republican Oncology Center, Syktyvkar, , Russian Federation
Tula Regional Clinical Hospital, Tula, , Russian Federation
Yaroslavl Regional Clinical Hospital, Yaroslavl, , Russian Federation
University Hospital with Outpatient Clinic F.D. Roosevelt, Banska Bystrica, , Slovakia
Saint Cyril and Metod University Hospital Bratislava, Bratislava, , Slovakia
Hospital del Mar, Barcelona, , Spain
Cherkasy Regional Oncology Center, Regional Treatment and Diagnostics Hematology Center, Cherkasy, , Ukraine
Dnipropetrovsk City Multispecialty Clinical Hospital #4, Dnipropetrovsk, , Ukraine
National Research Center for Radiation Medicine, Institute of Clinical Radiology, Kiev, , Ukraine
Institute of Blood Pathology and Transfusion Medicine, Lviv, , Ukraine
O.F. Herbachevskyi Regional Clinical Hospital, Zhytomyr, , Ukraine
Contact Details
Name: Heinz Gisslinger, MD
Affiliation: Med Uni Wien
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
