<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/NCT03825744</url>
  </required_header>
  <id_info>
    <org_study_id>HR-TPO-SAA-III</org_study_id>
    <nct_id>NCT03825744</nct_id>
  </id_info>
  <brief_title>Hetrombopag or Placebo in Treatment-Naive Severe Aplastic Anemia</brief_title>
  <official_title>A Phase III Multicenter Randomized Study of Hetrombopag or Placebo in Treatment-Naive Severe Aplastic Anemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</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>
      This is a multicenter, randomized, placebo-control, phase III study to investigate&#xD;
      hetrombopag in subjects with severe AA who are treated naive.&#xD;
&#xD;
      180 treated naive patients with SAA will be enrolled in the study. The primary objective of&#xD;
      the study will be the rate of complete hematologic response at six months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 5, 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of complete hematologic response at six months.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Severe Aplastic Anemia</condition>
  <arm_group>
    <arm_group_label>Hetrombopag Olamine+Standard Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo+Standard Therapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hetrombopag Olamine+Standard Therapy</intervention_name>
    <description>once daily</description>
    <arm_group_label>Hetrombopag Olamine+Standard Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo+Standard Therapy</intervention_name>
    <description>once daily</description>
    <arm_group_label>Placebo+Standard Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.15 Years to 75 Years (weight greater than 50 kg if Age &lt; 18 years old). 2.Severe aplastic&#xD;
        anemia characterized by Bone marrow cell proliferation less than 25 percent (If ≥25% but&#xD;
        &lt;50%, the remaining hematopoietic cells should be &lt;30%) AND At least two of the following:&#xD;
        Absolute neutrophil count &lt;0.5×109/L; Platelet count &lt;20×109/L; Absolute reticulocyte count&#xD;
        &lt;20×109/L.&#xD;
&#xD;
        3.Unsuitable or unwilling to perform hematopoietic stem cell transplantation (HSCT).&#xD;
&#xD;
        4.Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of whole blood cell reduction due to other causes or bone marrow&#xD;
             hypoproliferative diseases.&#xD;
&#xD;
          2. Subjects who have previously received immunosuppressive therapy with mycophenolate&#xD;
             mofetil, sirolimus, high dose cyclophosphamide (≥45mg/kg/d), alemtuzumab, etc；or have&#xD;
             treated with thrombopoietin receptor agonist (eg, eltrombopag, romiplostim, rhTPO,&#xD;
             etc.) prior to randomization.&#xD;
&#xD;
          3. Previous history of hematopoietic stem cell transplantation.&#xD;
&#xD;
          4. Subjects who is known or suspected of contraindications or hypersensitivity to&#xD;
             Hetrombopag's API (Active Pharmaceutical Ingredient).&#xD;
&#xD;
          5. Evidence of clonal cytogenetic abnormalities at the time of screening.&#xD;
&#xD;
          6. Bleeding and/or Infection not adequately responding to appropriate therapy.&#xD;
&#xD;
          7. Any laboratory or clinical evidence for HIV infection. Any clinical history for&#xD;
             hepatitis C infection; chronic hepatitis B infection; or any evidence for active&#xD;
             hepatitis at the time of subjects screening.&#xD;
&#xD;
          8. ALT&gt; 2.5 x upper limit of normal (ULN), AST&gt; 2.5 x upper limit of normal (ULN) DBLI&gt;&#xD;
             1.5 x upper limit of normal (ULN), Scr&gt; upper limit of normal (ULN).&#xD;
&#xD;
          9. Subjects with uncontrolled hypertension (&gt;180/100mmHg), severe arrhythmia (such as&#xD;
             complete left bundle branch block, QT interval prolongation (Bazetts formula), torsade&#xD;
             ventricular tachycardia, etc.), unstable angina, pulmonary hypertension at the time of&#xD;
             screening.&#xD;
&#xD;
         10. Subjects diagnosed with cirrhosis or portal hypertension.&#xD;
&#xD;
         11. Subjects with malignant solid tumors of any organ system within 5 years prior to&#xD;
             screening, with or without treatment, metastasis or recurrence, except for local&#xD;
             cutaneous basal cell carcinoma; subjects with hematological tumors found previously or&#xD;
             during screening.&#xD;
&#xD;
         12. Subjects with deep vein thrombosis, myocardial infarction, stroke or peripheral&#xD;
             arterial embolization within 12 months prior to randomization.&#xD;
&#xD;
         13. Female subjects who are nursing or pregnant.&#xD;
&#xD;
         14. Subjects cannot comply with effective contraception.&#xD;
&#xD;
         15. Subjects have participated in other clinical trial within the 3 months prior to study&#xD;
             entry.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ya-Qi Shen</last_name>
    <phone>+86-18036617093</phone>
    <email>shenyaqi@hrglobe.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Blood Diseases Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fengkui Zhang</last_name>
      <email>zhfk@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>July 28, 2022</last_update_submitted>
  <last_update_submitted_qc>July 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SAA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Aplastic</mesh_term>
  </condition_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/NCT03825744
org study id: HR-TPO-SAA-III
nct id: NCT03825744
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multicenter, randomized, placebo-control, phase III study to investigate
      hetrombopag in subjects with severe AA who are treated naive.

      180 treated naive patients with SAA will be enrolled in the study. The primary objective of
      the study will be the rate of complete hematologic response at six months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Rate of complete hematologic response at six months.
time frame: 6 months
arm group label: Hetrombopag Olamine+Standard Therapy
arm group type: Experimental
arm group label: Placebo+Standard Therapy
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Hetrombopag Olamine+Standard Therapy
description: once daily
arm group label: Hetrombopag Olamine+Standard Therapy
intervention type: Drug
intervention name: Placebo+Standard Therapy
description: once daily
arm group label: Placebo+Standard Therapy
criteria: 
gender: All
minimum age: 15 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ya-Qi Shen
phone: +86-18036617093
email: shenyaqi@hrglobe.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Anemia
mesh term: Anemia, Aplastic