AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study.
Status:
Completed
Trial end date:
2021-04-29
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
AOP Orphan Pharmaceuticals AG
Collaborators:
PharmaEssentia (Co-Sponsor for USA) PharmaEssentia Corporation (for the U.S.)