AOP2014 in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study. (CONTI-PV)
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. 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||An Open-label, Multicenter, Phase IIIb Study Assessing the Long-term Efficacy and Safety of AOP2014 in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study.|
- Hct level of 40 - 42% without phlebotomies. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2014|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Drug: 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.
Other Name: AOP2014
This is a Phase III, single arm, open-label continuation of the PROUD-PV study performed in adults diagnosed with Polycythemia Vera (PV). Only the patients who received AOP2014 in the primary study, PROUD-PV, and completed the end of study visit will be enrolled into this continuation study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02218047
|Contact: Oleh Zagrijtschuk, MD||+43-1-5037244 - email@example.com|
|Contact: Michael Zörer, PhD||+43-1-5037244 - firstname.lastname@example.org|
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|Principal Investigator:||Heinz Gisslinger, MD||Med Uni Wien|