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/NCT06036966</url>
    </required_header>
    <id_info>
      <org_study_id>SYSKY-2023-764-02</org_study_id>
      <nct_id>NCT06036966</nct_id>
    </id_info>
    <brief_title>The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients</brief_title>
    <official_title>The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Niraparib brings a better prognosis to those with advanced ovarian cancer and has been&#xD;
        approved by the Food and Drug Administration（FDA ）and National Medical Products&#xD;
        Administration（NMPA）as one of the maintenance therapies for the advanced ovarian cancer&#xD;
        patients. Thrombocytopenia is one of the adverse effects of Niraparib, with a 61% overall&#xD;
        incidence and 34% of the grade 3~4 incidence. Thrombocytopenia may cause suspension or dose&#xD;
        reduction of Niraparib which will affect the therapeutic effect of the drug.&#xD;
  &#xD;
        At present, the drugs recommended by the guidelines for the treatment of thrombocytopenia are&#xD;
        recombinant thrombopoietin (rhTPO), recombinant interleukin 11 (rhIL-11), TPO receptor&#xD;
        agonist (TPO-RA). Hetrombopag is one of the TPO-RA, which is recommended by the Chinese&#xD;
        expert consensus to cure the thrombocytopenia caused by poly adenosinediphosphate ribose&#xD;
        polymerase（PARP） inhibitors, including Niraparib. However, is it effective when it is used as&#xD;
        the primary prevention during the maintenance therapy of Niraparib? This single-arm study&#xD;
        aims to explore the efficacy and safety of hetrombopag for the prevention of thrombocytopenia&#xD;
        caused by Niraparib maintenance therapy in advanced ovarian cancer patients. 34 patients will&#xD;
        be recruited and they will take hetrombopag 5mg per day for 8 weeks when they initiate the&#xD;
        maintenance therapy with Niraparib. The primary endpoint of this study is the rate of&#xD;
        thrombocytopenia according to Common Terminology Criteria for Adverse Events 5.0（CTCAE5.0）.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 16, 2023</start_date>
    <completion_date type="Anticipated">July 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 15, 2025</primary_completion_date>
    <phase>Phase 2</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>efficacy of hetrombopag</measure>
      <time_frame>from the date of recruitment to the time of 12 weeks</time_frame>
      <description>incidence of thrombocytopenia according to Common Terminology Criteria for Adverse Events 5.0(CTCAE5.0)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>incidence of Niraparib suspension</measure>
      <time_frame>from the date of recruitment to the time of 12 weeks</time_frame>
      <description>incidence of Niraparib suspension due to thrombocytopenia</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">34</enrollment>
    <condition>Thrombocytopenia</condition>
    <arm_group>
      <arm_group_label>Hetrombopag</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>single-arm</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Hetrombopag</intervention_name>
      <description>All the enrolled 34 patients will be given hetrombopag 5mg per day for 8 weeks when they start to take Niraparib as maintenance therapy</description>
      <arm_group_label>Hetrombopag</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-75 years;&#xD;
  &#xD;
            2. Ovarian cancer patients using niraparib as maintenance therapy;&#xD;
  &#xD;
            3. Estimated survival≥ 12 weeks;&#xD;
  &#xD;
            4. Eastern Cooperative Oncology Group Physical Score(ECOG PS) : 0-2;&#xD;
  &#xD;
            5. Adequate function of organs:&#xD;
  &#xD;
          (1) Platelet count 100-300*109/L, neutrophil count≥2.0*109/L, hemoglobin 100-150g/L; (2)&#xD;
          Renal function: Cr≤1.5 upper limit of normal（ULN）; (3) Endogenous creatinine clearance&#xD;
          (Ccr) ≥ 55 ml/min; (4) Liver function: total bilirubin ≤1.5 upper limit of normal（ULN）; (5)&#xD;
          Alanine aminotransferase（ALT）and aspartate aminotransferase（AST）≤3 upper limit of&#xD;
          normal（ULN）; (6) Coagulation function: PT≤1.5 upper limit of normal（ULN）; 6. No serious&#xD;
          complications (including active gastrointestinal bleeding, perforation, jaundice,&#xD;
          gastrointestinal obstruction, non-cancerous fever&gt; 38℃)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with the following hematopoietic system diseases: leukemia, primary immune&#xD;
               thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic&#xD;
               syndrome, etc;&#xD;
  &#xD;
            2. Thrombocytopenia caused by non-anti-tumor therapy within 6 months before screening,&#xD;
               including chronic liver disease, hypersplenism, infection and bleeding, etc;&#xD;
  &#xD;
            3. Imaging examination shows bone marrow invasion or bone marrow metastasis, such as&#xD;
               Positron Emission Computed Tomography（PET-CT）, Magnetic Resonance Imaging（MRI）or&#xD;
               nuclear scan;&#xD;
  &#xD;
            4. Patients with antiphospholipid syndrome;&#xD;
  &#xD;
            5. Platelet transfusion or used TPO-RA, rhTPO and other platelet-raising drugs within 3&#xD;
               days before screening;&#xD;
  &#xD;
            6. Patients with known or expected hypersensitivity or intolerance to the active&#xD;
               ingredient or excipients of Hetrombopag&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jing Li, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>miaofang Wu, Doctor</last_name>
      <phone>+8613828494674</phone>
      <email>wmiaofang@mail.sysu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>miaofang Wu</last_name>
      <phone>+8613828494674</phone>
      <email>wmiaofang@mail.sysu.edu.cn</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Niraparib</keyword>
    <keyword>Hetrombopag</keyword>
    <keyword>Primary prevention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thrombocytopenia</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/NCT06036966
  org study id: SYSKY-2023-764-02
  nct id: NCT06036966
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Niraparib brings a better prognosis to those with advanced ovarian cancer and has been
        approved by the Food and Drug Administration（FDA ）and National Medical Products
        Administration（NMPA）as one of the maintenance therapies for the advanced ovarian cancer
        patients. Thrombocytopenia is one of the adverse effects of Niraparib, with a 61% overall
        incidence and 34% of the grade 3~4 incidence. Thrombocytopenia may cause suspension or dose
        reduction of Niraparib which will affect the therapeutic effect of the drug.
  
        At present, the drugs recommended by the guidelines for the treatment of thrombocytopenia are
        recombinant thrombopoietin (rhTPO), recombinant interleukin 11 (rhIL-11), TPO receptor
        agonist (TPO-RA). Hetrombopag is one of the TPO-RA, which is recommended by the Chinese
        expert consensus to cure the thrombocytopenia caused by poly adenosinediphosphate ribose
        polymerase（PARP） inhibitors, including Niraparib. However, is it effective when it is used as
        the primary prevention during the maintenance therapy of Niraparib? This single-arm study
        aims to explore the efficacy and safety of hetrombopag for the prevention of thrombocytopenia
        caused by Niraparib maintenance therapy in advanced ovarian cancer patients. 34 patients will
        be recruited and they will take hetrombopag 5mg per day for 8 weeks when they initiate the
        maintenance therapy with Niraparib. The primary endpoint of this study is the rate of
        thrombocytopenia according to Common Terminology Criteria for Adverse Events 5.0（CTCAE5.0）.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: efficacy of hetrombopag
  time frame: from the date of recruitment to the time of 12 weeks
  description: incidence of thrombocytopenia according to Common Terminology Criteria for Adverse Events 5.0(CTCAE5.0)
  measure: incidence of Niraparib suspension
  time frame: from the date of recruitment to the time of 12 weeks
  description: incidence of Niraparib suspension due to thrombocytopenia
  arm group label: Hetrombopag
  arm group type: Experimental
  description: single-arm
  intervention type: Drug
  intervention name: Hetrombopag
  description: All the enrolled 34 patients will be given hetrombopag 5mg per day for 8 weeks when they start to take Niraparib as maintenance therapy
  arm group label: Hetrombopag
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jing Li, Doctor
  role: Principal Investigator
  affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  last name: miaofang Wu, Doctor
  phone: +8613828494674
  email: wmiaofang@mail.sysu.edu.cn
  last name: miaofang Wu
  phone: +8613828494674
  email: wmiaofang@mail.sysu.edu.cn
  responsible party type: Sponsor
  mesh term: Thrombocytopenia
  sharing ipd: No