<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/NCT01732081</url>
  </required_header>
  <id_info>
    <org_study_id>5452</org_study_id>
    <nct_id>NCT01732081</nct_id>
  </id_info>
  <brief_title>&quot;Real-life&quot; Cohort of Patients With Chronic Hepatitis B Virus Infection</brief_title>
  <official_title>Hepatitis B Cohort: Predictive Factors of the Outcome of Chronic Hepatitis B Virus Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is estimated that 350-400 million people worldwide are chronically infected with hepatitis&#xD;
      B virus (HBV). Cirrhosis and hepatocellular carcinoma are major complications of chronic HBV&#xD;
      infection and are responsible of about 500,000 deaths each year. Although some predictive&#xD;
      factors of the outcome of chronic HBV infection were reported, it remains needed to more&#xD;
      precisely determine the factors which are associated with the outcome in non-selected&#xD;
      patients. Indeed, these factors should help to identify patients who are likely to have a&#xD;
      better or worse evolution of their chronic HBV infection over time and thus, to adapt their&#xD;
      clinical management and monitoring.Therefore, our purpose is to constitute a &quot;real-life&quot;&#xD;
      cohort of non-selected patients to create a database of epidemiological, clinical,&#xD;
      biological, virological and therapeutic parameters, in order to determine factors associated&#xD;
      with the outcome of chronic HBV infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2011</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>to determine factors associated with the outcome of chronic HBV infection</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Patients with chronic hepatitis B virus infection</arm_group_label>
    <description>Patients chronically infected with hepatitis B virus (HBV), and followed in university hospital of Strasbourg, France</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients chronically infected with hepatitis B virus (HBV), and followed in university&#xD;
        hospital of Strasbourg, France&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or&#xD;
             hepatitis D virus (HDV)&#xD;
&#xD;
          -  Decompensated cirrhosis&#xD;
&#xD;
          -  History of liver transplantation&#xD;
&#xD;
          -  History of hepatocellular carcinoma (HCC)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>François HABERSETZER, MD</last_name>
      <phone>+33(0)3 69 55 10 09</phone>
      <email>francois.habersetzer@chru-strasbourg.fr</email>
    </contact>
    <investigator>
      <last_name>François HABERSETZER, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>November 16, 2012</last_update_submitted>
  <last_update_submitted_qc>November 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatitis B</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>Virus Diseases</mesh_term>
    <mesh_term>Herpesviridae Infections</mesh_term>
    <mesh_term>Hepatitis</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/NCT01732081
org study id: 5452
nct id: NCT01732081
lead sponsor: 
has dmc: No
It is estimated that 350-400 million people worldwide are chronically infected with hepatitis
      B virus (HBV). Cirrhosis and hepatocellular carcinoma are major complications of chronic HBV
      infection and are responsible of about 500,000 deaths each year. Although some predictive
      factors of the outcome of chronic HBV infection were reported, it remains needed to more
      precisely determine the factors which are associated with the outcome in non-selected
      patients. Indeed, these factors should help to identify patients who are likely to have a
      better or worse evolution of their chronic HBV infection over time and thus, to adapt their
      clinical management and monitoring.Therefore, our purpose is to constitute a "real-life"
      cohort of non-selected patients to create a database of epidemiological, clinical,
      biological, virological and therapeutic parameters, in order to determine factors associated
      with the outcome of chronic HBV infection.
observational model: Cohort
time perspective: Prospective
measure: to determine factors associated with the outcome of chronic HBV infection
time frame: 10 years
arm group label: Patients with chronic hepatitis B virus infection
description: Patients chronically infected with hepatitis B virus (HBV), and followed in university hospital of Strasbourg, France
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Virus Diseases
mesh term: Herpesviridae Infections
mesh term: Hepatitis