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/NCT06004856</url>
    </required_header>
    <id_info>
      <org_study_id>ICP-CL-00126</org_study_id>
      <nct_id>NCT06004856</nct_id>
    </id_info>
    <brief_title>Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia</brief_title>
    <official_title>A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beijing InnoCare Pharma Tech Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beijing InnoCare Pharma Tech Co., Ltd.</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>
        A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the&#xD;
        Efficacy and Safety of Orelabrutinib in Adult Patients with Chronic Primary Immune&#xD;
        Thrombocytopenia&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Durable response rate</measure>
      <time_frame>Throughout the study period, an average of 6 months</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">195</enrollment>
    <condition>Chronic Primary Immune Thrombocytopenia (ITP)</condition>
    <arm_group>
      <arm_group_label>Orelabrutinib</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Qrelabrutinib</intervention_name>
      <description>Qrelabrutinib once daily (QD)</description>
      <arm_group_label>Orelabrutinib</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo once daily (QD)</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects have had a detailed understanding of the nature, significance, possible&#xD;
               benefits, possible inconveniences, and potential risks of the trial, understood the&#xD;
               study procedures, and voluntarily signed a written ICF before the study.&#xD;
  &#xD;
            2. Males or females aged from 18 to 80 years (including the marginal values).&#xD;
  &#xD;
            3. With a body weight of ≥ 35 kg at screening.&#xD;
  &#xD;
            4. In accordance with the diagnosis of chronic (≥ 12 months) ITP&#xD;
  &#xD;
            5. Patients who have previously received at least one anti-ITP first-line standard&#xD;
               treatment (glucocorticoids and/or intravenous immunoglobulin) cannot maintain&#xD;
               efficacy, or relapse, or cannot tolerate standard treatment, or have insufficient&#xD;
               response.&#xD;
  &#xD;
            6. Women of childbearing potential must take a complementary barrier method of&#xD;
               contraception in combination with a highly effective method of contraception at&#xD;
               screening, throughout the trial, and within 90 days after the last dose of the&#xD;
               investigational drug.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Severe hemorrhage occurred within 4 weeks prior to screening.&#xD;
  &#xD;
            2. Subjects suffered from severe ITP at screening and were not eligible for participation&#xD;
               in this study as judged by the investigator.&#xD;
  &#xD;
            3. Subjects had autoimmune systemic diseases other than ITP unless they would not affect&#xD;
               the evaluation of the study results in the judgment of the investigator and sponsor&#xD;
               medical monitor.&#xD;
  &#xD;
            4. Subjects had multiple immune hemocytopenia.&#xD;
  &#xD;
            5. Subjects had inherited thrombocytopenia or secondary ITP.&#xD;
  &#xD;
            6. Subjects had a history of arterial or venous thromboembolism within 6 months prior to&#xD;
               screening.&#xD;
  &#xD;
            7. Received prohibited medications within protocol-specified period before the first&#xD;
               dose.&#xD;
  &#xD;
            8. Received blood transfusion (including platelet transfusion) within 2 weeks prior to&#xD;
               the first dose of the investigational drug.&#xD;
  &#xD;
            9. Participated in another study of the investigational drug (and/or investigational&#xD;
               device) within 30 days or within 5 half-lives prior to screening (whichever is&#xD;
               longer), or is currently participating in another study of the investigational drug&#xD;
               (and /or investigational device).&#xD;
  &#xD;
           10. The last administration of strong CYP3A inhibitors or strong CYP3A inducers (include&#xD;
               food, western medicine, traditional Chinese medicine) is within 14 days (or 5&#xD;
               half-lives, whichever is longer) prior to the first dose, or planned to take a drug or&#xD;
               food with a strong inhibition or induction of CYP3A during the study period.&#xD;
  &#xD;
           11. Received a major surgery (including splenectomy) or trauma (except biopsy) within 28&#xD;
               days prior to the first dose of the investigational drug, or expected to receive a&#xD;
               major surgery during the study treatment period.&#xD;
  &#xD;
           12. Received splenectomy and had a prior history of overwhelming post-splenectomy&#xD;
               infection (OPSI).&#xD;
  &#xD;
           13. Had a history of alcohol or drug abuse currently or within the past 1 year, excepting&#xD;
               nicotine and caffeine.&#xD;
  &#xD;
           14. Received a COVID-19 vaccine, live vaccine, or live-attenuated vaccine within 1 month&#xD;
               prior to screening or during the screening period.&#xD;
  &#xD;
           15. Previous exposure to BTK inhibitors.&#xD;
  &#xD;
           16. Laboratory results did not meet protocol requirements.&#xD;
  &#xD;
           17. Pregnant or lactating women.&#xD;
  &#xD;
           18. Subjects whose blood cannot be collected, or who had contraindications for blood&#xD;
               collection.&#xD;
  &#xD;
           19. Other conditions that were not appropriate for participation in the trial as&#xD;
               considered by the investigators.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Alexia Lu</last_name>
      <phone>010-66609745</phone>
      <email>CO_HGRAC@innocarepharma.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The first affiliated hospital of bengbu medical college</name>
        <address>
          <city>Bengbu</city>
          <state>Anhui</state>
          <zip>233004</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Feng Zhang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Anhui Medical University</name>
        <address>
          <city>Hefei</city>
          <state>Anhui</state>
          <zip>230022</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Qingshu Zeng</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Beijing CHAO-YANG Hospital Capital Medcal University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100044</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wenming Chen</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nanfang Hospital, Southern Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510515</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jing Sun</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Henan Cancer Hospital</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <zip>450004</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hu Zhou</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Zhengzhou University</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <zip>450052</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Fang Wang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430022</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Heng Mei</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Yichang Central People's Hospital</name>
        <address>
          <city>Yichang</city>
          <state>Hubei</state>
          <zip>443008</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jingming Guo</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jiangxi Provincial People's Hospital</name>
        <address>
          <city>Nanchang</city>
          <state>Jiangxi</state>
          <zip>330006</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Chenghao Jin</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Nanchang University</name>
        <address>
          <city>Nanchang</city>
          <state>Jiangxi</state>
          <zip>330006</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ruibin Huang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Qilu hospital of shandong university</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250012</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ming Hou, PhD</last_name>
        <phone>18560087007</phone>
        <email>houming@medmail.com.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ruijin Hospital, Shanghai Jiao Tong University School of Medicine</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200020</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Junmin Li</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Institute of Hematology &amp; Blood Diseases Hospital, Chinese Academy of Medical Sciences</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300020</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Lei Zhang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Kunming Medical University</name>
        <address>
          <city>Kunming</city>
          <state>Yunnan</state>
          <zip>650000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zeping Zhou</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 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>Thrombocytopenia</mesh_term>
      <mesh_term>Purpura, Thrombocytopenic, Idiopathic</mesh_term>
    </condition_browse>
    <!-- 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/NCT06004856
  org study id: ICP-CL-00126
  nct id: NCT06004856
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the
        Efficacy and Safety of Orelabrutinib in Adult Patients with Chronic Primary Immune
        Thrombocytopenia
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Durable response rate
  time frame: Throughout the study period, an average of 6 months
  arm group label: Orelabrutinib
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Qrelabrutinib
  description: Qrelabrutinib once daily (QD)
  arm group label: Orelabrutinib
  intervention type: Drug
  intervention name: Placebo
  description: Placebo once daily (QD)
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Alexia Lu
  phone: 010-66609745
  email: CO_HGRAC@innocarepharma.com
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  country: China
  responsible party type: Sponsor
  mesh term: Thrombocytopenia
  mesh term: Purpura, Thrombocytopenic, Idiopathic