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/NCT05989958</url>
    </required_header>
    <id_info>
      <org_study_id>HCB-201</org_study_id>
      <nct_id>NCT05989958</nct_id>
    </id_info>
    <brief_title>The Safety and Tolerability Study of HepaCure in Chinese Subjects With Acute-On-Chronic Liver Failure</brief_title>
    <official_title>A Multicenter, Randomized, Controlled, Open-Label Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability and Efficacy of HepaCure Plus DPMAS Versus DPMAS Alone in Chinese Subjects With Acute-On-Chronic Liver Failure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hexaell Biotech Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hexaell Biotech 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, controlled, open-label phase 1/2 clinical study conducted&#xD;
        in China to evaluate the efficacy, safety and tolerability of hiHep cell-based bio-artificial&#xD;
        liver support system (HepaCure) plus DPMAS versus DPMAS alone in Chinese subjects with&#xD;
        acute-on-chronic liver failure（ACLF）.&#xD;
  &#xD;
        Phase 1 is a multicenter, open label study to evaluate the safety and tolerability of single&#xD;
        dose and multiple doses of HepaCure with different treatment duration plus DPMAS in ACLF&#xD;
        subjects respectively.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>Phase 1</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>Safety outcome</measure>
      <time_frame>28 days after the end of last treatment</time_frame>
      <description>The adverse events (AE), Serious adverse event (SAE), adverse events of special concern (AESI), and device defects (leakage caused by the quality problem of the plasma biological purification column itself) of the safety paramater will be collected, and the safety and tolerability within 14 days and 28 days will be evaluated from the end of the last treatment</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Acute on Chronic Hepatic Failure</condition>
    <condition>Liver Failure</condition>
    <condition>Hepatitis</condition>
    <arm_group>
      <arm_group_label>HepaCure</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive Hepacure treatment on top of DPMAS</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>HepaCure</intervention_name>
      <description>HepaCure will be administered in extracorporal dialysis for single dose or multiple doses with different treatment duration on top of DPMAS.</description>
      <arm_group_label>HepaCure</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Able to communicate effectively with investigators and sign the informed consent form&#xD;
               (ICF) voluntarily.&#xD;
  &#xD;
            2. Age: ≥ 18 years and ≤ 65 years.&#xD;
  &#xD;
            3. Body weight: ≥ 40kg;&#xD;
  &#xD;
            4. Met the criteria of ACLF in the early and middle stages in screening period&#xD;
               (Guidelines for the Diagnosis and Treatment of Liverfilture (2018 Edition)): base on&#xD;
               chronic liver disease, acute jaundice deepened and coagulation dysfunction caused by&#xD;
               various inducements, manifested as extreme fatigue, with obvious gastrointestinal&#xD;
               symptoms such as anorexia, vomiting, abdominal distention, etc; Progressive deepening&#xD;
               of jaundice, serum TBil ≥ 171 μmol/L or increase ≥ 17.1 μmol/L daily; with bleeding&#xD;
               tendencies or manifestations (bleeding spots or ecchymosis), or 20%&lt;PTA ≤ 40% (or 1.5&#xD;
               ≤ INR&lt;2.6), and other reasons excluded.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with primary or metastatic liver cancer.&#xD;
  &#xD;
            2. Subjects with severe esophageal/gastric varices and high risk of bleeding, with&#xD;
               positive red signs, or with previous active bleeding, as indicated by gastroscopy or&#xD;
               imaging examination results.&#xD;
  &#xD;
            3. Pneumonia refer to the diagnostic criteria of the American Society of Infectious&#xD;
               Diseases/American Thoracic Society for adult severe pneumonia in 2007), abdominal&#xD;
               infection (after reasonable antibiotic treatment, there are still Peritonitis&#xD;
               manifestations or white blood cells in ascites&gt;0.1 × 10 9/L), etc.&#xD;
  &#xD;
            4. Subjects with serious uncontrolled infections, including sepsis, septic shock, severe&#xD;
               pneumonia (refers to the diagnostic criteria of the American Society of Infectious&#xD;
               Diseases/American Thoracic Society for adult severe pneumonia in 2007), abdominal&#xD;
               infection (exist Peritonitis manifestations or white blood cells in ascites&gt;0.1 × 10&#xD;
               9/L after reasonable antibiotic treatment), etc;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>YU Chen, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Beijing YouAn Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>YU Chen, MD</last_name>
      <phone>86-13391663900</phone>
      <email>chybeyond@163.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 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>Liver Failure</mesh_term>
      <mesh_term>Hepatic Insufficiency</mesh_term>
      <mesh_term>End Stage Liver Disease</mesh_term>
      <mesh_term>Acute-On-Chronic Liver Failure</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/NCT05989958
  org study id: HCB-201
  nct id: NCT05989958
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a multicenter, randomized, controlled, open-label phase 1/2 clinical study conducted
        in China to evaluate the efficacy, safety and tolerability of hiHep cell-based bio-artificial
        liver support system (HepaCure) plus DPMAS versus DPMAS alone in Chinese subjects with
        acute-on-chronic liver failure（ACLF）.
  
        Phase 1 is a multicenter, open label study to evaluate the safety and tolerability of single
        dose and multiple doses of HepaCure with different treatment duration plus DPMAS in ACLF
        subjects respectively.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Safety outcome
  time frame: 28 days after the end of last treatment
  description: The adverse events (AE), Serious adverse event (SAE), adverse events of special concern (AESI), and device defects (leakage caused by the quality problem of the plasma biological purification column itself) of the safety paramater will be collected, and the safety and tolerability within 14 days and 28 days will be evaluated from the end of the last treatment
  arm group label: HepaCure
  arm group type: Experimental
  description: Patients will receive Hepacure treatment on top of DPMAS
  intervention type: Combination Product
  intervention name: HepaCure
  description: HepaCure will be administered in extracorporal dialysis for single dose or multiple doses with different treatment duration on top of DPMAS.
  arm group label: HepaCure
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: YU Chen, MD
  role: Study Chair
  affiliation: Beijing YouAn Hospital
  last name: YU Chen, MD
  phone: 86-13391663900
  email: chybeyond@163.com
  responsible party type: Sponsor
  mesh term: Liver Failure
  mesh term: Hepatic Insufficiency
  mesh term: End Stage Liver Disease
  mesh term: Acute-On-Chronic Liver Failure