Study to Assess the Self-administration of AOP2014 Using a Pen, Developed for the Treatment of Polycythemia Vera Patients (PEN-PV)
Polycythemia Vera
About this trial
This is an interventional treatment trial for Polycythemia Vera focused on measuring Pegylated-Proline-interferon alpha-2b (AOP2014), Polycythemia Vera, PEN-PV, PROUD-PV, CONTINUATION-PV, AOP Orphan, Polycythemia, Hematologic Diseases, Myeloproliferative Disorders, Bone Marrow Diseases, Interferon-alpha, Peginterferon alfa-2b
Eligibility Criteria
Inclusion Criteria:
Patients who either completed the 12 months AOP2014 treatment arm of the PROUD-PV study, or are currently participating in the CONTINUATION-PV, and at the "EoT visit" (End of treatment visit) of the PROUD-PV study or two weeks after the last assessment visit of the CONTINUATION-PV study, fulfill at least one of the following criteria:
- Normalization of at least two out of three main blood parameters (Hct (Hematocrit), PLTs (Platelets) and WBCs (white blood cells) if these parameters were moderately increased (Hct<50%, WBCs<20 x 109/L, PLTs<600 x 109/L) at baseline visit of the PROUD-PV study, OR
- >35% decrease of at least two out of three main blood parameters (Hct, PLTs and WBCs) if these parameters were massively increased (Hct>50%, WBCs>20 x 109/L, PLTs >600 x 109/L), at baseline visit of the PROUD-PV study, OR
- Normalization of spleen size, if spleen was enlarged at baseline visit of the PROUD-PV study, OR
- Otherwise a clear, medically verified benefit from treatment with AOP2014 (e.g. normalization of disease-related micro-vasculatory symptoms, substantial decrease of JAK2 (Januskinase 2) allelic burden).
- Signed written ICF.
Exclusion Criteria:
Withdrawal criteria, as specified in the PROUD-PV and CONTINUATION-PV studies, which mandate treatment discontinuation.
- Non-recovery from the AOP2014 related toxicities to the grade (usually, Grade I) which allows continuation of the treatment.
- HADS (Hospital Anxiety and Depression Scale) score of 11 or higher on either or both of the subscales, and /or development or worsening of clinically significant depression or suicidal thoughts.
- Progressive and clinically significant increase of liver enzyme levels despite dose reduction, or if such increase is accompanied by increased bilirubin level, any signs or symptoms of a clinically significant autoimmune disease.
- Clinically significant development of a new ophthalmologic disorder, or worsening of a pre-existing one, during the study.
- Loss of efficacy of AOP2014 or any comparable situation where no further benefits of treatment continuation are expected by the investigator.
Sites / Locations
- LKH Graz
- University Hospital Innsbruck
- Elisabethinen Hospital Linz
- Salzburg Regional Hospital
- Hanusch Hospital
- Medical University Vienna
- Hospital Wels-Grieskirchen
- Specialized Hospital for Active Treatment of Hematological Diseases
- Multiprofile Hospital for Active Treatment - Hristo Botev, Vratsa, First Department of Internal Medicine
- University Hospital Brno
- University Hospital Hradec Kralove
- Institute of Hematology and Blood Transfusion
- University Hospital Kralovske Vinohrady
- University Hospital Motol
- Institute Paoli-Calmettes
- Hospital Saint-Louis
- Clinical Research Center CIC
- St Istvan and St Laszlo Hospital of Budapest
- University of Debrecen
- Bekes County Pandy Kalman Hospital, 1st Department of Medicine, Hematology
- Kaposi Mor County Teaching Hospital
- University of Szeged, Albert Szent-Gyorgyi Clinical Center, Koranyi fasor 6
- Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice
- University Hospital in Cracow
- Independent Public Teaching Hospital No.1 in Lublin
- Fryderyk Chopin Provincial Specialized Hospital
- Nicolaus Copernicus Municipal Specialist Hospital
- Institute of Hematology and Transfusion Medicine
- University Hospital with Outpatient Clinic F.D. Roosevelt
- Saint Cyril and Metod University Hospital Bratislava
- Cherkasy Regional Oncology Center, Regional Treatment and Diagnostics Hematology Center
- Dnipropetrovsk City Multispecialty Clinical Hospital #4
- National Research Center for Radiation Medicine, Institute of Clinical Radiology
- Institute of Blood Pathology and Transfusion Medicine
- O.F. Herbachevskyi Regional Clinical Hospital
Arms of the Study
Arm 1
Other
Pegylated- Proline-Interferon alpha-2b
Pegylated-Proline-Interferon alpha-2b in a Pre-filled Pen single arm