<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/NCT01679769</url>
  </required_header>
  <id_info>
    <org_study_id>2012-455</org_study_id>
    <secondary_id>81170386</secondary_id>
    <nct_id>NCT01679769</nct_id>
  </id_info>
  <brief_title>Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis B</brief_title>
  <official_title>Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Municipal Science &amp; Technology Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our study is to evaluate liver fibrosis using biochemical markers, FibroScan, and&#xD;
      radiology methods in patients with chronic hepatitis B in mainland China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to Nov, 2015, total of 818 patients with chronic HBV infection had been enrolled in the&#xD;
      study. Paired blood and liver biopsy specimen had been collected. The serum samples stored at&#xD;
      -80 degree Celsius. All the liver biopsy samples were judged by three pathology experts,&#xD;
      according to Ishak standard.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy</measure>
    <time_frame>within two weeks after liver biopsy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsy</measure>
    <time_frame>within two weeks after liver biopsy</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">818</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      liver biopsy samples and blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients with chronic hepatitis B or compensated cirrhosis due to chronic hepatits B virus&#xD;
        (HBV) infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of chronic hepatitis B or compensated cirrhosis due to chronic&#xD;
             hepatitis B virus infection&#xD;
&#xD;
          -  agree to have liver biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of decompensated cirrhosis due to hepatitis B virus or inactive&#xD;
             carrier&#xD;
&#xD;
          -  liver diseases due to other origin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guiqiang Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hong Zhao, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Bei Jing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 1, 2012</study_first_submitted>
  <study_first_submitted_qc>September 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>November 4, 2015</last_update_submitted>
  <last_update_submitted_qc>November 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Guiqiang Wang</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>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>
  <!-- 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/NCT01679769
org study id: 2012-455
secondary id: 81170386
nct id: NCT01679769
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of our study is to evaluate liver fibrosis using biochemical markers, FibroScan, and
      radiology methods in patients with chronic hepatitis B in mainland China.
Up to Nov, 2015, total of 818 patients with chronic HBV infection had been enrolled in the
      study. Paired blood and liver biopsy specimen had been collected. The serum samples stored at
      -80 degree Celsius. All the liver biopsy samples were judged by three pathology experts,
      according to Ishak standard.
time perspective: Prospective
measure: Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy
time frame: within two weeks after liver biopsy
measure: Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsy
time frame: within two weeks after liver biopsy
liver biopsy samples and blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Guiqiang Wang, MD
role: Principal Investigator
affiliation: Peking University First Hospital
last name: Hong Zhao, MD
role: Study Director
affiliation: Peking University First Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Guiqiang Wang
investigator title: Professor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic