xml: <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/NCT06033586</url>
    </required_header>
    <id_info>
      <org_study_id>PTG-300-21</org_study_id>
      <nct_id>NCT06033586</nct_id>
    </id_info>
    <brief_title>Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera</brief_title>
    <acronym>THRIVE</acronym>
    <official_title>An Extension Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera (THRIVE)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Protagonist Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Protagonist Therapeutics, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to assess long-term safety and efficacy of rusfertide in&#xD;
        subjects with polycythemia vera. Subjects who complete dosing with rusfertide until the&#xD;
        end-of-treatment visit of a Phase 2 or Phase 3 study and meet the inclusion/exclusion&#xD;
        criteria for this study, are eligible to participate in this open-label study and continue&#xD;
        treatment with rusfertide.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an open-label study designed to assess the long-term safety and efficacy of&#xD;
        rusfertide. This study aims to provide long-term rusfertide treatment to subjects who&#xD;
        complete dosing until the end-of-treatment of a previous Phase 2 or Phase 3 rusfertide study&#xD;
        and are likely to continue benefiting from treatment with rusfertide based on their improved&#xD;
        control of hematocrit levels &lt;45% and reduced need for therapeutic phlebotomies. This study&#xD;
        will provide long-term rusfertide treatment to these subjects and obtain data on safety and&#xD;
        efficacy of long-term treatment with rusfertide.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2026</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Open-label rusfertide</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hematocrit</measure>
      <time_frame>0-2 years</time_frame>
      <description>Median hematocrit</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Phlebotomies</measure>
      <time_frame>0-2 years</time_frame>
      <description>Number of phlebotomies</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Polycythemia Vera</condition>
    <arm_group>
      <arm_group_label>Open-label rusfertide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Open-label rusfertide</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Open-label rusfertide</intervention_name>
      <description>subcutaneous rusfertide</description>
      <arm_group_label>Open-label rusfertide</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject who has completed at least 12 months of dosing with rusfertide and&#xD;
               successfully completed the end of treatment visit of a previous Phase 2 or Phase 3&#xD;
               study of rusfertide.&#xD;
  &#xD;
            -  Subject understands the study procedures, is willing and able to adhere to study&#xD;
               requirements and agrees to participate in the study by giving written informed&#xD;
               consent.&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Subject who, in the opinion of the investigator, should not participate in the study.&#xD;
  &#xD;
            -  Subject who discontinue early from a previous rusfertide study for reasons other than&#xD;
               enrolling in this study.&#xD;
  &#xD;
            -  Pregnant or lactating females.&#xD;
  &#xD;
            -  Women of childbearing potential (WOCBP) who do not agree to use medically acceptable&#xD;
               contraception (&lt;1% annual failure rate) during the study and for 30 days after the&#xD;
               last dose of study drug.&#xD;
  &#xD;
            -  Men with partners of childbearing potential who do not agree to use medically&#xD;
               acceptable contraception (&lt;1% annual failure rate) during the study and for 90 days&#xD;
               after the last dose of study drug.&#xD;
  &#xD;
            -  Men who do not agree to use a condom during the study and for 90 days after the last&#xD;
               dose of study drug regardless of the partner's childbearing potential.&#xD;
  &#xD;
            -  A female subject intends to donate eggs (ova, oocytes) for the purposes of assisted&#xD;
               reproduction during the study and for a period of 30 days after receiving the last&#xD;
               dose of study drug.&#xD;
  &#xD;
            -  A male subject intends to donate sperm for the purpose of reproduction during the&#xD;
               study and for a minimum of 90 days after receiving the last dose of study drug.&#xD;
  &#xD;
            -  Plan to use investigational treatment other than rusfertide during the course of the&#xD;
               study or within 28 days after last rusfertide dose.&#xD;
  &#xD;
            -  Subject with hypersensitivity to rusfertide or to any of the excipients.&#xD;
  &#xD;
            -  In the investigator's opinion the subject has progressive disease that cannot be&#xD;
               managed by adjusting concurrent cytoreductive therapy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033586
  org study id: PTG-300-21
  nct id: NCT06033586
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this clinical trial is to assess long-term safety and efficacy of rusfertide in
        subjects with polycythemia vera. Subjects who complete dosing with rusfertide until the
        end-of-treatment visit of a Phase 2 or Phase 3 study and meet the inclusion/exclusion
        criteria for this study, are eligible to participate in this open-label study and continue
        treatment with rusfertide.
  This is an open-label study designed to assess the long-term safety and efficacy of
        rusfertide. This study aims to provide long-term rusfertide treatment to subjects who
        complete dosing until the end-of-treatment of a previous Phase 2 or Phase 3 rusfertide study
        and are likely to continue benefiting from treatment with rusfertide based on their improved
        control of hematocrit levels <45% and reduced need for therapeutic phlebotomies. This study
        will provide long-term rusfertide treatment to these subjects and obtain data on safety and
        efficacy of long-term treatment with rusfertide.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Open-label rusfertide
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Hematocrit
  time frame: 0-2 years
  description: Median hematocrit
  measure: Phlebotomies
  time frame: 0-2 years
  description: Number of phlebotomies
  arm group label: Open-label rusfertide
  arm group type: Experimental
  description: Open-label rusfertide
  intervention type: Drug
  intervention name: Open-label rusfertide
  description: subcutaneous rusfertide
  arm group label: Open-label rusfertide
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Polycythemia Vera
  mesh term: Polycythemia
  sharing ipd: No