<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/NCT02247752</url>
  </required_header>
  <id_info>
    <org_study_id>CHRO -2014-02</org_study_id>
    <nct_id>NCT02247752</nct_id>
  </id_info>
  <brief_title>Follow-up of HBsAg Inactive Carriers Study</brief_title>
  <acronym>PIBAC</acronym>
  <official_title>Follow-up of HBsAg Inactive Carriers Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Régional d'Orléans</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>INSERM U785-CNR Hôpital Paul Brousse 94800 VILLEJUIF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Faculté de mathématiques ORLEANS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Régional d'Orléans</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We&#xD;
      spoke first from HBsAg&quot; healthy carrier &quot;, then from &quot; asymptomatic carrier &quot;, last from&#xD;
      HBsAg&quot; inactive carrier &quot;. This definition continue to be not totally consensual. A very low&#xD;
      viral load (&lt; 2000 UI/ml) or undetectable, associated with repetitive normal transaminases&#xD;
      and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status&#xD;
      on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of&#xD;
      alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40&#xD;
      UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during a&#xD;
      year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some&#xD;
      patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently&#xD;
      normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in&#xD;
      order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver&#xD;
      cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant prognosis&#xD;
      criteria of unexpected arrival of such events. Secondary outcomes will evaluate HBsAg&#xD;
      quantification for the prognosis of such events or, in contrary HBs seroconversion; will&#xD;
      evaluate the influence of B genotype on HBsAg level; will evaluate the influence of&#xD;
      comorbidities on unexpected arrival of such events.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2014</start_date>
  <completion_date type="Actual">February 4, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2016</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of unfavourable liver events</measure>
    <time_frame>every year, during 5 years for each</time_frame>
    <description>The primary outcome that the study was designed to evaluate is the incidence of unfavourable liver events (chronic hepatitis B, liver cirrhosis, HCC) in a cohort of patients presumed to be &quot; HBsAg inactive carriers &quot;.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">619</enrollment>
  <condition>Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Inactive carriers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>inactive carrier</intervention_name>
    <description>Yearly demographic, clinic, biologic and ultrasonic data collection realized during usual follow-up as recommended.&#xD;
Yearly centralisation of a complementary biological analysis in Paul Brousse Hospital laboratory of virology.</description>
    <arm_group_label>Inactive carriers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HBsAg + since one year or more.&#xD;
&#xD;
               -  HBeAg -, anti-HBe antibodies +&#xD;
&#xD;
               -  HBV-DNA &lt; 20000 UI/ml on all dosages realized during past year (ultra-sensitive&#xD;
                  PCR with a detection threshold &lt; 20 UI/ml), at least 2 dosages during past year.&#xD;
&#xD;
               -  AST and ALT transaminases &lt; ULN on all dosages realized during past year (at&#xD;
                  least 3).&#xD;
&#xD;
               -  Age &gt; 18 and &lt; 70&#xD;
&#xD;
               -  We will include consecutively all encountered patients (consultation,&#xD;
                  hospitalization) and diagnosed as HBsAg inactive carriers in each participating&#xD;
                  center.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  anti-VHC antibodies +&#xD;
&#xD;
          -  anti-VHD antibodies +&#xD;
&#xD;
          -  anti-VIH antibodies +&#xD;
&#xD;
          -  genetic hemochromatosis&#xD;
&#xD;
          -  liver cirrhosis on liver biopsy or with non-invasive methods (Fibrometer, Fibroscan,&#xD;
             Fibrotest, Hepascore …)&#xD;
&#xD;
          -  Past or present treatment against HBV&#xD;
&#xD;
          -  Ultrasonic diagnosis of HCC or Portal Hypertension&#xD;
&#xD;
          -  non compliant patient whom 5 years follow-up seems uncertain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xavier CAUSSE</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHR Orleans</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ch General Du Pays D'Aix</name>
      <address>
        <city>Aix en Provence</city>
        <zip>13616</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH d'AVIGNON</name>
      <address>
        <city>Avignon</city>
        <zip>84902</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique de La Chataigneraie</name>
      <address>
        <city>Beaumont</city>
        <zip>63110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Besancon</name>
      <address>
        <city>Besancon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Bourgoin Jallieu</name>
      <address>
        <city>Bourgoin Jallieu</city>
        <zip>38300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Sainte Camille</name>
      <address>
        <city>Bry sur Marne</city>
        <zip>94360</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch de Caen</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Sud Fracilien Jean Jaures</name>
      <address>
        <city>Corbeil essonnes</city>
        <zip>91100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH CREIL</name>
      <address>
        <city>Creil</city>
        <zip>60109</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch de Creteil</name>
      <address>
        <city>Creteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de GONESSE</name>
      <address>
        <city>Gonesse</city>
        <zip>95503</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Du Palais</name>
      <address>
        <city>Grasse</city>
        <zip>06130</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch D'Hyeres</name>
      <address>
        <city>Hyeres</city>
        <zip>83407</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch de Lagny Marne La Valee</name>
      <address>
        <city>Jossigny</city>
        <zip>77600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chd Vendee</name>
      <address>
        <city>La Roche sur yon</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Du Mans</name>
      <address>
        <city>Le Mans</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center La Sauvegarde</name>
      <address>
        <city>Lyon</city>
        <zip>69009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch de Meaux</name>
      <address>
        <city>Meaux</city>
        <zip>77104</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH MELUN</name>
      <address>
        <city>Melun</city>
        <zip>77011</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Montelimar</name>
      <address>
        <city>Montelimar</city>
        <zip>26126</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch de Montfermeil</name>
      <address>
        <city>Montfermeil</city>
        <zip>93370</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34070</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Nanterre</name>
      <address>
        <city>Nanterre</city>
        <zip>92000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR d'ORLEANS</name>
      <address>
        <city>Orleans</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Paris 7</name>
      <address>
        <city>Paris</city>
        <zip>75007</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch de Pau</name>
      <address>
        <city>Pau</city>
        <zip>64000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Jean</name>
      <address>
        <city>Perpignan</city>
        <zip>66046</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch de La Region Annnecienne</name>
      <address>
        <city>Pringy</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Saint Brieuc</name>
      <address>
        <city>Saint Brieuc</city>
        <zip>22027</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch de Saint Denis</name>
      <address>
        <city>Saint Denis</city>
        <zip>93200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch de Vannes</name>
      <address>
        <city>Vannes</city>
        <zip>56017</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chi Villeneauve Saint Georges</name>
      <address>
        <city>Villeneuve Saint Georges</city>
        <zip>94190</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hepatitis</keyword>
  <keyword>HBV</keyword>
  <keyword>chronic hepatitis</keyword>
  <keyword>HCC</keyword>
  <keyword>cirrhosis</keyword>
  <keyword>quantitative HBsAg</keyword>
  <keyword>HBsAg inactive carriers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis B</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/NCT02247752
org study id: CHRO -2014-02
nct id: NCT02247752
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We
      spoke first from HBsAg" healthy carrier ", then from " asymptomatic carrier ", last from
      HBsAg" inactive carrier ". This definition continue to be not totally consensual. A very low
      viral load (< 2000 UI/ml) or undetectable, associated with repetitive normal transaminases
      and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status
      on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of
      alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40
      UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during a
      year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some
      patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently
      normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in
      order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver
      cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant prognosis
      criteria of unexpected arrival of such events. Secondary outcomes will evaluate HBsAg
      quantification for the prognosis of such events or, in contrary HBs seroconversion; will
      evaluate the influence of B genotype on HBsAg level; will evaluate the influence of
      comorbidities on unexpected arrival of such events.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of unfavourable liver events
time frame: every year, during 5 years for each
description: The primary outcome that the study was designed to evaluate is the incidence of unfavourable liver events (chronic hepatitis B, liver cirrhosis, HCC) in a cohort of patients presumed to be " HBsAg inactive carriers ".
arm group label: Inactive carriers
arm group type: Other
intervention type: Other
intervention name: inactive carrier
description: Yearly demographic, clinic, biologic and ultrasonic data collection realized during usual follow-up as recommended.
Yearly centralisation of a complementary biological analysis in Paul Brousse Hospital laboratory of virology.
arm group label: Inactive carriers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Xavier CAUSSE
role: Principal Investigator
affiliation: CHR Orleans
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country: France
responsible party type: Sponsor
mesh term: Hepatitis B
mesh term: Hepatitis