Study to Assess the Self-administration of AOP2014 Using a Pen, Developed for the Treatment of Polycythemia Vera Patients
Condition: Polycythemia Vera
MeSH terms: Polycythemia Vera; Polycythemia
Study type: Interventional
Phase: Phase 3

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 assess the ease of AOP2014 self-administration using dedicated
      questionnaires.

        -  To assess safety and tolerability: adverse events (AEs), laboratory parameters,
           electrocardiogram (ECG) throughout study.

        -  To assess maintenance of the blood efficacy parameters Hct (Hematocrit), WBC (white
           blood cells) and PLTs (platelets) and spleen size (comparing values at Visit P7 vs.
           values at Visit P1).

        -  To assess the feasibility of AOP2014 self-administration: defined as the ability of the
           patients to use the pen as a self-administration tool (ease of handling, safety,
           tolerability and efficacy).
    

Detailed description: 
      This is a Phase III, single-arm study performed in patients who completed the AOP2014 arm of
      the PROUD-PV study or are currently participating in the CONTINUATION-PV study. After signing
      the informed consent form (ICF), approximately 30 patients will be enrolled consecutively
      into the study at participating sites according to the inclusion and exclusion criteria.
    

Intervention name(s): Pegylated-Proline-Interferon alpha-2b in a Pre-filled Pen
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): AOP2014
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 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