<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/NCT03777969</url>
  </required_header>
  <id_info>
    <org_study_id>2018ZX10302204-001</org_study_id>
    <nct_id>NCT03777969</nct_id>
  </id_info>
  <brief_title>Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients</brief_title>
  <official_title>Precise Prediction System for Clinical Endpoint Events of Chronic Hepatitis B Patients in the Ear of Antiviral Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ShuGuang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Ditan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hangzhou Choutu Technology Co.,Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuxi Hisky Medical Technologies Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Friendship Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A total of 2000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1&#xD;
      year after antiviral therapy are enrolled. All the patients will receive original antiviral&#xD;
      treatment for the following 10 years. Patients will be assessed at baseline and at every six&#xD;
      months for blood count, liver function test, alpha fetoprotein (AFP), prothrombin time, liver&#xD;
      ultrasonography, liver stiffness measurement (LSM), Hepatitis B virus (HBV) DNA and HBV&#xD;
      serological markers. HBV-related endpoint events, including cirrhosis decompensations&#xD;
      (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma&#xD;
      (HCC), liver transplantation and liver-related death, will be collected during follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      No.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 29, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2028</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2028</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>HBV-related clinical endpoint events, including liver decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), HCC, liver transplantation and liver-related death</measure>
    <time_frame>1 to 10 years</time_frame>
    <description>Incidence of HBV-related clinical endpoint events during follow-ups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Predicted probability of HBV-related clinical endpoint events</measure>
    <time_frame>1 to 10 years</time_frame>
    <description>The predicted probability is measured by histological prediction model or non-invasive prediction model</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predicted probability of HBV-induced fibrosis/cirrhosis regression</measure>
    <time_frame>1 to 10 years</time_frame>
    <description>The predicted probability is measured by histological prediction model or non-invasive prediction model</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of HBV-induced liver fibrosis/cirrhosis regression</measure>
    <time_frame>1 to 10 years</time_frame>
    <description>Liver fibrosis regression was defined as decrease &gt;= 1 point by Ishak fibrosis scoring system (range from 0 to 6, higher values represent a worse outcome) or Predominantly Regressive in P-I-R ( predominantly progressive, indeterminate and predominately regressive) score</description>
  </secondary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Chronic Hepatitis b</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Liver biopsy and peripheral blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        CHB patients with liver biopsy performed at least 1 year after antiviral therapy; or CHB&#xD;
        patients with antiviral therapy for at least 1 year content to be performed liver biopsy at&#xD;
        enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Group 1: Patients with history of HBV-related clinical endpoint events&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  No age limit;&#xD;
&#xD;
          -  Male or female;&#xD;
&#xD;
          -  Patients with liver biopsy performed at least 1 year after antiviral therapy; patients&#xD;
             with history of clinical endpoint events (decompensated cirrhosis, hepatocellular&#xD;
             carcinoma, liver transplantation or liver-related death) after liver biopsy;&#xD;
&#xD;
          -  Patients with liver biopsy or liver stiffness or aspartate aminotransferase&#xD;
             (AST)-to-platelet (PLT) ratio index (APRI) before antiviral treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy,&#xD;
             esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis,&#xD;
             or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver&#xD;
             transplantation before liver biopsy;&#xD;
&#xD;
          -  Patients with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection,&#xD;
             alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced&#xD;
             liver injury, or other chronic liver diseases;&#xD;
&#xD;
          -  Patients with malignant lesion on liver image;&#xD;
&#xD;
          -  Patients with other uncured malignant tumors;&#xD;
&#xD;
          -  Patients with severe heart, lung, kidney, brain, blood, neuropsychiatric or other&#xD;
             organs diseases;&#xD;
&#xD;
          -  Pregnant or lactating women;&#xD;
&#xD;
          -  Patients with any other reasons not suitable for the study.&#xD;
&#xD;
        Group 2: Patients without history of clinical endpoint events&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  No age limit;&#xD;
&#xD;
          -  Male or female;&#xD;
&#xD;
          -  Patients with liver biopsy performed at least 1 year after antiviral therapy; or&#xD;
             chronic hepatitis B (CHB) patients with antiviral therapy at least 1 year content to&#xD;
             be performed liver biopsy at enrollment;&#xD;
&#xD;
          -  Patients with liver biopsy or liver stiffness or APRI before antiviral treatment;&#xD;
&#xD;
          -  Agree to be followed up regularly;&#xD;
&#xD;
          -  Signature of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy,&#xD;
             esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis,&#xD;
             or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver&#xD;
             transplantation;&#xD;
&#xD;
          -  Patients with HCV or HIV infection, alcoholic liver disease, autoimmune liver disease,&#xD;
             genetic liver disease, drug-induced liver injury, or other chronic liver diseases;&#xD;
&#xD;
          -  Patients with malignant lesion on liver image;&#xD;
&#xD;
          -  Patients with other uncured malignant tumors, exclude who were cured;&#xD;
&#xD;
          -  Patients with severe heart, lung, kidney, brain, blood, neuropsychiatric or other&#xD;
             organs diseases;&#xD;
&#xD;
          -  Pregnant or lactating women;&#xD;
&#xD;
          -  Patients with any other reasons not suitable for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong You, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Ditan Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100015</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Wuxi Hisky Medical Technologies Co., Ltd.</name>
      <address>
        <city>Wuxi</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hangzhou Choutu Technology Co.,Ltd.</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>October 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>September 2, 2022</last_update_submitted>
  <last_update_submitted_qc>September 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Hong You</investigator_full_name>
    <investigator_title>Vice President of Beijing Friendship Hospital</investigator_title>
  </responsible_party>
  <keyword>Chronic Hepatitis B</keyword>
  <keyword>Liver fibrosis/cirrhosis</keyword>
  <keyword>HBV-related endpoint events</keyword>
  <keyword>Precise prediction model</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03777969
org study id: 2018ZX10302204-001
nct id: NCT03777969
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A total of 2000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1
      year after antiviral therapy are enrolled. All the patients will receive original antiviral
      treatment for the following 10 years. Patients will be assessed at baseline and at every six
      months for blood count, liver function test, alpha fetoprotein (AFP), prothrombin time, liver
      ultrasonography, liver stiffness measurement (LSM), Hepatitis B virus (HBV) DNA and HBV
      serological markers. HBV-related endpoint events, including cirrhosis decompensations
      (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma
      (HCC), liver transplantation and liver-related death, will be collected during follow-up.
No.
observational model: Cohort
time perspective: Other
measure: HBV-related clinical endpoint events, including liver decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), HCC, liver transplantation and liver-related death
time frame: 1 to 10 years
description: Incidence of HBV-related clinical endpoint events during follow-ups
measure: Predicted probability of HBV-related clinical endpoint events
time frame: 1 to 10 years
description: The predicted probability is measured by histological prediction model or non-invasive prediction model
measure: Predicted probability of HBV-induced fibrosis/cirrhosis regression
time frame: 1 to 10 years
description: The predicted probability is measured by histological prediction model or non-invasive prediction model
measure: Percentage of HBV-induced liver fibrosis/cirrhosis regression
time frame: 1 to 10 years
description: Liver fibrosis regression was defined as decrease >= 1 point by Ishak fibrosis scoring system (range from 0 to 6, higher values represent a worse outcome) or Predominantly Regressive in P-I-R ( predominantly progressive, indeterminate and predominately regressive) score
Liver biopsy and peripheral blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Hong You, Doctor
role: Principal Investigator
affiliation: Beijing Friendship Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Friendship Hospital
investigator full name: Hong You
investigator title: Vice President of Beijing Friendship Hospital
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
sharing ipd: No