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/NCT06004791</url>
    </required_header>
    <id_info>
      <org_study_id>rHCsA</org_study_id>
      <nct_id>NCT06004791</nct_id>
    </id_info>
    <brief_title>A Prospective, Randomized, Controlled Study of rhTPO in Combination With Herombopag + CsA vs Herombopag + CsA for the Treatment of Primary TD-NSAA</brief_title>
    <official_title>A Prospective, Randomized, Controlled Study of rhTPO in Combination With Herombopag + CsA vs Herombopag + CsA for the Treatment of Primary Transfusion-dependent NSAA</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Aplastic anemia (AA) is a group of clinical syndromes. Treatment options are very limited.&#xD;
        The results of a previous clinical study showed good efficacy and a high safety profile of&#xD;
        herombopag in improving thrombocytopenia, but this result needs to be supported by more data.&#xD;
  &#xD;
        In our study, patients who were willing to participate in this study and were diagnosed with&#xD;
        transfusion-dependent non-heavy aplastic anemia were randomized to the rhTPO combined with&#xD;
        herombopag + cyclosporine group and given rhTPO (at a dose of 1500 U by subcutaneous&#xD;
        injection once daily for 7 d, 28 d for 3 courses) +Herombopag(10 mg/day for 3 months) +&#xD;
        cyclosporine (3-5 mg/kg/d for 3 months). -5 mg/kg/d for at least 6 months) and herombopag +&#xD;
        cyclosporine (10 mg/day for 3 months) + cyclosporine (3-5 mg/kg/d for at least 6 months) in&#xD;
        the herombopag+ cyclosporine group to observe the efficacy and safety.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aplastic anemia (AA) is a group of clinical syndromes caused by a significant decrease in&#xD;
        bone marrow hematopoietic tissue from different etiologies, resulting in hematopoietic&#xD;
        failure. The prevalence of AA in China is 7.4 per 1 million. It peaks in the 15-25 and 60+&#xD;
        age groups and is more common in men than women. Treatment options are very limited. The&#xD;
        results of a previous clinical study showed good efficacy and a high safety profile of&#xD;
        herombopag in improving thrombocytopenia, but this result needs to be supported by more data.&#xD;
  &#xD;
        In our study, patients who were willing to participate in this study and were diagnosed with&#xD;
        transfusion-dependent non-heavy aplastic anemia were randomized to the rhTPO combined with&#xD;
        herombopag + cyclosporine group and given rhTPO (at a dose of 1500 U by subcutaneous&#xD;
        injection once daily for 7 d, 28 d for 3 courses) +Herombopag(10 mg/day for 3 months) +&#xD;
        cyclosporine (3-5 mg/kg/d for 3 months). -5 mg/kg/d for at least 6 months) and Herombopag +&#xD;
        cyclosporine (10 mg/day for 3 months) + cyclosporine (3-5 mg/kg/d for at least 6 months) in&#xD;
        the herombopag+ cyclosporine group to observe the efficacy and safety.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>Phase 4</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>ORR at 3 Months</measure>
      <time_frame>Week 14</time_frame>
      <description>After 3 months of treatment, ORR was calculated by measuring platelets, hemoglobin, neutrophils, and transfusion independence</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ORR at 6 Months</measure>
      <time_frame>Week 26</time_frame>
      <description>After 6 months of treatment, ORR was calculated by measuring platelets, hemoglobin, neutrophils, and transfusion independence</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>3 months of drug safety</measure>
      <time_frame>Week 14</time_frame>
      <description>Assessing the incidence and severity of adverse events; All adverse events that occur or worsen within 3 months of treatment will be reported</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6 months of drug safety</measure>
      <time_frame>Week 26</time_frame>
      <description>Assessing the incidence and severity of adverse events; All adverse events that occur or worsen within 6 months of treatment will be reported</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Aplastic Anemia</condition>
    <condition>Drug Effect</condition>
    <arm_group>
      <arm_group_label>Herombopag + CsA</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Herombopag 10mg/ day, adjust the dose according to the blood image, the course of treatment is at least 3 months, CsA: 3-5 mg/kg/d, adjust the valley concentration 100-200ng/ml, at least 6 months, effective patients continue to use for 1 year, and then gradually reduce the dose.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>rhTPO combined with Herombopag + CsA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administer rhTPO (15000U, subcutaneously once daily for 7 days, once a month for 3 months),Herombopag 10mg/day, adjust dose according to blood picture for at least 3 months, CsA: 3-5 mg/kg/d, adjust trough concentration 100-200ng/ml for at least 6 months, continue for 1 year if effective, then gradually reduce dose</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Herombopag + CsA</intervention_name>
      <description>Herombopag（10mg/d）+CsA(3-5 mg/kg/d, adjust the grain concentration 100-200ng/ml)</description>
      <arm_group_label>Herombopag + CsA</arm_group_label>
      <other_name>control</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>rhTPO combined with Herombopag + CsA</intervention_name>
      <description>rhTPO (15000U, subcutaneous injection, once a day for 7 days, once a month for 3 months)，Herombopag（10mg/d）+CsA(3-5 mg/kg/d, adjust the grain concentration 100-200ng/ml)</description>
      <arm_group_label>rhTPO combined with Herombopag + CsA</arm_group_label>
      <other_name>experimental</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥18 years old.&#xD;
  &#xD;
            2. Clearly diagnosed untreated NSAA.&#xD;
  &#xD;
            3. At least one of the following conditions was met at the time of enrollment: hemoglobin&#xD;
               &lt;90 g/L. Platelet &lt;30×109/L, neutrophils &lt;1.0×109/L.&#xD;
  &#xD;
            4. Baseline liver and kidney function (ALT, AST, Cr) was less than 2 times the normal&#xD;
               value.&#xD;
  &#xD;
            5. No active infection; Not pregnant or breastfeeding.&#xD;
  &#xD;
            6. Agree to sign the consent form.&#xD;
  &#xD;
            7. The Eastern Cancer Collaboration Group (ECOG) score was 0-2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. pancytopenia caused by other causes, such as myelodysplastic syndrome (MDS).&#xD;
  &#xD;
            2. There is cytogenetic evidence of clonal hematologic bone marrow diseases (MDS, AML).&#xD;
  &#xD;
            3. PNH clone ≥50%.&#xD;
  &#xD;
            4. Had received hematopoietic stem cell transplantation (HSCT) before enrollment.&#xD;
  &#xD;
            5. Immunosuppressive therapy such as ATG or cyclosporine use for more than 2 weeks.&#xD;
  &#xD;
            6. Infection or bleeding that is not controlled by standard treatment.&#xD;
  &#xD;
            7. Allergic to recombinant TPO or Hitrepopar.&#xD;
  &#xD;
            8. Active HIV, HCV or HBV infection or cirrhosis or portal hypertension.&#xD;
  &#xD;
            9. Any concomitant malignancy or local basal cell carcinoma of the skin within 5 years.&#xD;
  &#xD;
           10. Previous history of thromboembolic events, heart attack or stroke (including&#xD;
               antiphospholipid antibody syndrome) and current use of anticoagulants.&#xD;
  &#xD;
           11. Women who are pregnant or nursing (lactation).&#xD;
  &#xD;
           12. Have participated in other clinical trials within 3 months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Bing Han, Doctor</last_name>
      <phone>+8601069151235</phone>
      <email>hanbing_li@sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking union medical college hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
      <investigator_full_name>Bing Han</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anemia, Aplastic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>individual participant data would be accepted upon request</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>always</ipd_time_frame>
      <ipd_access_criteria>email request</ipd_access_criteria>
    </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/NCT06004791
  org study id: rHCsA
  nct id: NCT06004791
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Aplastic anemia (AA) is a group of clinical syndromes. Treatment options are very limited.
        The results of a previous clinical study showed good efficacy and a high safety profile of
        herombopag in improving thrombocytopenia, but this result needs to be supported by more data.
  
        In our study, patients who were willing to participate in this study and were diagnosed with
        transfusion-dependent non-heavy aplastic anemia were randomized to the rhTPO combined with
        herombopag + cyclosporine group and given rhTPO (at a dose of 1500 U by subcutaneous
        injection once daily for 7 d, 28 d for 3 courses) +Herombopag(10 mg/day for 3 months) +
        cyclosporine (3-5 mg/kg/d for 3 months). -5 mg/kg/d for at least 6 months) and herombopag +
        cyclosporine (10 mg/day for 3 months) + cyclosporine (3-5 mg/kg/d for at least 6 months) in
        the herombopag+ cyclosporine group to observe the efficacy and safety.
  Aplastic anemia (AA) is a group of clinical syndromes caused by a significant decrease in
        bone marrow hematopoietic tissue from different etiologies, resulting in hematopoietic
        failure. The prevalence of AA in China is 7.4 per 1 million. It peaks in the 15-25 and 60+
        age groups and is more common in men than women. Treatment options are very limited. The
        results of a previous clinical study showed good efficacy and a high safety profile of
        herombopag in improving thrombocytopenia, but this result needs to be supported by more data.
  
        In our study, patients who were willing to participate in this study and were diagnosed with
        transfusion-dependent non-heavy aplastic anemia were randomized to the rhTPO combined with
        herombopag + cyclosporine group and given rhTPO (at a dose of 1500 U by subcutaneous
        injection once daily for 7 d, 28 d for 3 courses) +Herombopag(10 mg/day for 3 months) +
        cyclosporine (3-5 mg/kg/d for 3 months). -5 mg/kg/d for at least 6 months) and Herombopag +
        cyclosporine (10 mg/day for 3 months) + cyclosporine (3-5 mg/kg/d for at least 6 months) in
        the herombopag+ cyclosporine group to observe the efficacy and safety.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: ORR at 3 Months
  time frame: Week 14
  description: After 3 months of treatment, ORR was calculated by measuring platelets, hemoglobin, neutrophils, and transfusion independence
  measure: ORR at 6 Months
  time frame: Week 26
  description: After 6 months of treatment, ORR was calculated by measuring platelets, hemoglobin, neutrophils, and transfusion independence
  measure: 3 months of drug safety
  time frame: Week 14
  description: Assessing the incidence and severity of adverse events; All adverse events that occur or worsen within 3 months of treatment will be reported
  measure: 6 months of drug safety
  time frame: Week 26
  description: Assessing the incidence and severity of adverse events; All adverse events that occur or worsen within 6 months of treatment will be reported
  arm group label: Herombopag + CsA
  arm group type: Placebo Comparator
  description: Herombopag 10mg/ day, adjust the dose according to the blood image, the course of treatment is at least 3 months, CsA: 3-5 mg/kg/d, adjust the valley concentration 100-200ng/ml, at least 6 months, effective patients continue to use for 1 year, and then gradually reduce the dose.
  arm group label: rhTPO combined with Herombopag + CsA
  arm group type: Experimental
  description: Administer rhTPO (15000U, subcutaneously once daily for 7 days, once a month for 3 months),Herombopag 10mg/day, adjust dose according to blood picture for at least 3 months, CsA: 3-5 mg/kg/d, adjust trough concentration 100-200ng/ml for at least 6 months, continue for 1 year if effective, then gradually reduce dose
  intervention type: Drug
  intervention name: Herombopag + CsA
  description: Herombopag（10mg/d）+CsA(3-5 mg/kg/d, adjust the grain concentration 100-200ng/ml)
  arm group label: Herombopag + CsA
  other name: control
  intervention type: Drug
  intervention name: rhTPO combined with Herombopag + CsA
  description: rhTPO (15000U, subcutaneous injection, once a day for 7 days, once a month for 3 months)，Herombopag（10mg/d）+CsA(3-5 mg/kg/d, adjust the grain concentration 100-200ng/ml)
  arm group label: rhTPO combined with Herombopag + CsA
  other name: experimental
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bing Han, Doctor
  phone: +8601069151235
  email: hanbing_li@sina.com
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Peking Union Medical College Hospital
  investigator full name: Bing Han
  investigator title: Professor
  mesh term: Anemia, Aplastic
  sharing ipd: Yes
  ipd description: individual participant data would be accepted upon request
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: always
  ipd access criteria: email request