<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02218047</url>
  </required_header>
  <id_info>
    <org_study_id>CONTINUATION-PV</org_study_id>
    <secondary_id>2014-001357-17</secondary_id>
    <nct_id>NCT02218047</nct_id>
  </id_info>
  <brief_title>AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study.</brief_title>
  <acronym>CONTI-PV</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AOP Orphan Pharmaceuticals AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PharmaEssentia Corporation (for the U.S.)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AOP Orphan Pharmaceuticals AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic&#xD;
      increase of red blood cells and frequently also of white blood cells. The &quot;thickening&quot; of the&#xD;
      blood in relation with a modified function of the cells has several consequences like&#xD;
      increased blood pressure, pruritus of the skin, fatigue, disturbed blood circulation in the&#xD;
      brain as well as fingers and toes and an increased risk of arterial and venous thrombosis&#xD;
      (thrombosis is the formation of a blood clot in a vessel); like stroke, cardiac infarction,&#xD;
      deep vein thrombosis in the legs. In case of a strong increase of platelets there is an&#xD;
      additional risk of bleedings. As the disease progresses the size of spleen and liver&#xD;
      increased in most cases and the bone marrow shows signs of fibrosis. In some cases of PV a&#xD;
      progression at a later time point to a leukemia (increased formation of white blood cells)&#xD;
      can occur.&#xD;
&#xD;
      The aim of this study is to show that the study drug AOP2014 (pegylated proline interferon&#xD;
      alpha-2b) has the long term efficacy and safety in controlling the disease. A comparison arm&#xD;
      is receiving best available therapy as selected by the investigator. Response to the&#xD;
      treatment is measured by several blood parameters as well as size of the spleen.&#xD;
&#xD;
      Interferon-alpha has been shown to be effective in controlling the blood parameters by&#xD;
      immunologically influencing the blood building cells. This can lead to a suppression of the&#xD;
      disease-causing stem cells and help healthy stem cells to proliferate. Through this mechanism&#xD;
      it is possible that Interferon-alpha can avoid long-term damaging effects of the disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase III, parallel-arm, open-label continuation of the PROUD-PV study performed in&#xD;
      adults diagnosed with Polycythemia Vera (PV). Patients who received AOP2014 in the primary&#xD;
      study, PROUD-PV will continue on AOP2014, patients who received HU in the PROUD-PV study will&#xD;
      receive best available therapy as selected by the investigator. Only patients who completed&#xD;
      PROUD-PV including the end of study visit will be enrolled into this continuation study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">April 29, 2021</completion_date>
  <primary_completion_date type="Actual">April 29, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease response at quarterly assessment visits</measure>
    <time_frame>3 years</time_frame>
    <description>The primary efficacy endpoint will be the rate of disease response at assessment visits (every 3 months).&#xD;
The co-primary efficacy evaluation criterion will be (1) disease response defined as hematologic response: Hct&lt;45% without phlebotomy (at least 3 months since the last phlebotomy), PLTs&lt;400 x 109/L, WBCs&lt;10 x 109/L, and normal spleen size, and (2) disease response defined as hematologic response (Hct&lt;45% without phlebotomy (at least 3 months since the last phlebotomy), PLTs&lt;400 x 109/L, WBCs&lt;10 x 109/L), resolution and/or clinically improvement of disease-related signs (clinical significant splenomegaly) and disease-related symptoms (microvascular disturbances, pruritus, headache).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Polycythemia Vera</condition>
  <arm_group>
    <arm_group_label>Best available therapy (BAT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Best available therapy, as chosen by the investigator for patients who had been on HU in the 1 Year PROUD-PV study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pegylated-Proline-interferon alpha-2b</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AOP2014 for those patients who had been on AOP2014 in the PROUD-PV study</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pegylated-Proline-interferon alpha-2b</intervention_name>
    <description>Subjects will continue to receive the dosage which delivers the optimal disease response (hematocrit [Hct]&lt;45%, platelets [PLTs]&lt;400 x 109/L and leukocytes [WBCs]&lt;10 x 109/L), as determined in the PROUD-PV study, preferably at the level of target blood values.</description>
    <arm_group_label>Pegylated-Proline-interferon alpha-2b</arm_group_label>
    <other_name>AOP2014</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Best available therapy (BAT)</intervention_name>
    <description>Best available therapy as selected by the investigator</description>
    <arm_group_label>Best available therapy (BAT)</arm_group_label>
    <other_name>best available therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who completed the 12 months AOP2014 treatment arm of the PROUD-PV study and&#xD;
             at the &quot;end-of-treatment visit&quot; (EoT) of the PROUD-PV study who fulfill at least one&#xD;
             of the following criteria:&#xD;
&#xD;
               -  normalization of at least two out of three main blood parameters (Hct, PLTs and&#xD;
                  WBCs) if these parameters were moderately increased (Hct&lt;50%, WBC&lt;20 x 109/L,&#xD;
                  PLTs&lt;600 x 109/L) at baseline of the PROUD-PV study, OR&#xD;
&#xD;
               -  &gt;35% decrease of at least two out of three main blood parameters (Hct, PLTs and&#xD;
                  WBCs) if these parameters were massively increased (Hct&gt;50%, WBCs&gt;20 x 109/L,&#xD;
                  PLTs&gt;600 x 109/L), at baseline of the PROUD-PV study, OR&#xD;
&#xD;
               -  normalization of spleen size, if spleen was enlarged at baseline of the PROUD-PV&#xD;
                  study, OR&#xD;
&#xD;
               -  otherwise a clear, medically verified benefit from treatment with AOP2014 (e.g.&#xD;
                  normalization of disease-related micro-vasculatory symptoms, substantial decrease&#xD;
                  of JAK2 allelic burden).&#xD;
&#xD;
          2. Signed written ICF.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Withdrawal criteria, as specified in the PROUD-PV study, which mandate treatment&#xD;
        discontinuation:&#xD;
&#xD;
          1. Non-recovery from the AOP2014 related toxicities to the grade (usually, Grade I) which&#xD;
             allows continuation of the treatment.&#xD;
&#xD;
          2. HADS score of 11 or higher on either or both of the subscales, and /or development or&#xD;
             worsening of the clinically significant depression or suicidal thoughts.&#xD;
&#xD;
          3. Progressive and clinically significant increase of liver enzyme levels despite dose&#xD;
             reduction, or if such increase is accompanied by increased bilirubin level, any signs&#xD;
             or symptoms of a clinically significant autoimmune disease.&#xD;
&#xD;
          4. Clinically significant development of a new ophthalmologic disorder, or worsening of a&#xD;
             pre-existing one, during the study.&#xD;
&#xD;
          5. Loss of efficacy of AOP2014 or any comparable situation where no further benefits of&#xD;
             treatment continuation are expected by the investigator.&#xD;
&#xD;
        The main efficacy evaluation criterion will be disease response defined as Hct&lt;45% without&#xD;
        phlebotomy (at least 3 months since the last phlebotomy), PLTs&lt;400 x 109/L, WBCs&lt;10 x&#xD;
        109/L, and normal spleen size.&#xD;
&#xD;
        The main efficacy endpoint will be the maintenance rate of disease response at assessment&#xD;
        visits (every three months).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heinz Gisslinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Med Uni Wien</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LKH Graz</name>
      <address>
        <city>Graz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elisabethinen Hospital Linz</name>
      <address>
        <city>Linz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salzburg Regional Hospital</name>
      <address>
        <city>Salzburg</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanusch Hospital</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University Vienna</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Wels-Grieskirchen</name>
      <address>
        <city>Wels</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment &quot;Sveti Georgi&quot;, Plovdiv</name>
      <address>
        <city>Plovdiv</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialized Hospital for Active Treatment of Hematological Diseases</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment &quot;Sveta Marina&quot;, Varna</name>
      <address>
        <city>Varna</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment - Hristo Botev, Vratsa, First Department of Internal Medicine</name>
      <address>
        <city>Vratsa</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Brno</name>
      <address>
        <city>Brno</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Hradec Kralove</name>
      <address>
        <city>Hradec Kralove</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Kralovske Vinohrady</name>
      <address>
        <city>Prague</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Motol</name>
      <address>
        <city>Prague</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute Paoli-Calmettes</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Saint-Louis</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center CIC</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aachen University Hospital, Medical Clinic IV</name>
      <address>
        <city>Aachen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Bonn, Center for Internal Medicine, Medical Clinic and Outpatient Clinic III</name>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Carl Gustav Carus, Medical Clinic and Polyclinic I</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Istvan and St Laszlo Hospital of Budapest</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Debrecen</name>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bekes County Pandy Kalman Hospital, 1st Department of Medicine, Hematology</name>
      <address>
        <city>Gyula</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaposi Mor County Teaching Hospital</name>
      <address>
        <city>Kaposvar</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Szeged, Albert Szent-Gyorgyi Clinical Center, Koranyi fasor 6</name>
      <address>
        <city>Szeged</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital in Cracow</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Independent Public Teaching Hospital No.1 in Lublin</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fryderyk Chopin Provincial Specialized Hospital</name>
      <address>
        <city>Rzeszow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nicolaus Copernicus Municipal Specialist Hospital</name>
      <address>
        <city>Torun</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Hematology and Transfusion Medicine</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emergency Clinical County Hospital Brasov</name>
      <address>
        <city>Brasov</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bucharest University Emergency Hospital</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coltea Clinical Hospital</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baranov Republican Hospital</name>
      <address>
        <city>Petrozavodsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samara Kalinin Regional Clinical Hospital</name>
      <address>
        <city>Samara</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Komi Republican Oncology Center</name>
      <address>
        <city>Syktyvkar</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tula Regional Clinical Hospital</name>
      <address>
        <city>Tula</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yaroslavl Regional Clinical Hospital</name>
      <address>
        <city>Yaroslavl</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital with Outpatient Clinic F.D. Roosevelt</name>
      <address>
        <city>Banska Bystrica</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Cyril and Metod University Hospital Bratislava</name>
      <address>
        <city>Bratislava</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cherkasy Regional Oncology Center, Regional Treatment and Diagnostics Hematology Center</name>
      <address>
        <city>Cherkasy</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dnipropetrovsk City Multispecialty Clinical Hospital #4</name>
      <address>
        <city>Dnipropetrovsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Center for Radiation Medicine, Institute of Clinical Radiology</name>
      <address>
        <city>Kiev</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Blood Pathology and Transfusion Medicine</name>
      <address>
        <city>Lviv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>O.F. Herbachevskyi Regional Clinical Hospital</name>
      <address>
        <city>Zhytomyr</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Bulgaria</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Ukraine</country>
  </location_countries>
  <removed_countries>
    <country>Belgium</country>
    <country>Czech Republic</country>
    <country>Italy</country>
  </removed_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>May 27, 2021</last_update_submitted>
  <last_update_submitted_qc>May 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pegylated-Proline-interferon alpha-2b (AOP2014)</keyword>
  <keyword>Polycythemia Vera</keyword>
  <keyword>PROUD-PV</keyword>
  <keyword>CONTINUATION-PV</keyword>
  <keyword>AOP Orphan</keyword>
  <keyword>Polycythemia</keyword>
  <keyword>Hematologic Diseases</keyword>
  <keyword>Myeloproliferative Disorders</keyword>
  <keyword>Bone Marrow Diseases</keyword>
  <keyword>Interferon-alpha</keyword>
  <keyword>Peginterferon alfa-2b</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycythemia Vera</mesh_term>
    <mesh_term>Polycythemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Interferon-alpha</mesh_term>
    <mesh_term>Interferon alpha-2</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02218047
org study id: CONTINUATION-PV
secondary id: 2014-001357-17
nct id: NCT02218047
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Disease response at quarterly assessment visits
time frame: 3 years
description: The primary efficacy endpoint will be the rate of disease response at assessment visits (every 3 months).
The co-primary efficacy evaluation criterion will be (1) disease response defined as hematologic response: Hct<45% without phlebotomy (at least 3 months since the last phlebotomy), PLTs<400 x 109/L, WBCs<10 x 109/L, and normal spleen size, and (2) disease response defined as hematologic response (Hct<45% without phlebotomy (at least 3 months since the last phlebotomy), PLTs<400 x 109/L, WBCs<10 x 109/L), resolution and/or clinically improvement of disease-related signs (clinical significant splenomegaly) and disease-related symptoms (microvascular disturbances, pruritus, headache).
arm group label: Best available therapy (BAT)
arm group type: Active Comparator
description: Best available therapy, as chosen by the investigator for patients who had been on HU in the 1 Year PROUD-PV study
arm group label: Pegylated-Proline-interferon alpha-2b
arm group type: Experimental
description: AOP2014 for those patients who had been on AOP2014 in the PROUD-PV study
intervention type: Drug
intervention name: Pegylated-Proline-interferon alpha-2b
description: 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.
arm group label: Pegylated-Proline-interferon alpha-2b
other name: AOP2014
intervention type: Drug
intervention name: Best available therapy (BAT)
description: Best available therapy as selected by the investigator
arm group label: Best available therapy (BAT)
other name: best available therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Heinz Gisslinger, MD
role: Principal Investigator
affiliation: Med Uni Wien
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country: Austria
country: Bulgaria
country: Czechia
country: France
country: Germany
country: Hungary
country: Poland
country: Romania
country: Russian Federation
country: Slovakia
country: Spain
country: Ukraine
country: Belgium
country: Czech Republic
country: Italy
responsible party type: Sponsor
mesh term: Polycythemia Vera
mesh term: Polycythemia
mesh term: Interferons
mesh term: Interferon-alpha
mesh term: Interferon alpha-2