<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/NCT01732354</url>
  </required_header>
  <id_info>
    <org_study_id>IX-US-174-0206</org_study_id>
    <nct_id>NCT01732354</nct_id>
  </id_info>
  <brief_title>Study for Consolidation Period of Chronic Hepatitis B</brief_title>
  <official_title>A Prospective Study to Investigate the Consolidation Period of 12 Months Compared to 18 Months After Tenofovir Therapy With HBeAg Seroconversion in Asian Chronic Hepatitis B HBeAg-positive Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tainan Municipal Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tainan Municipal Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to clarify the issue of adequate duration of consolidation period of&#xD;
      Chronic hepatitis B infection with antiviral treatment with Tenofovir which could strike a&#xD;
      balance between durable HBeAg seroconversion and avoiding long-term inevitable serological or&#xD;
      virological recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to practice guidelines of American Association of the Study of Liver Diseases, in&#xD;
      patients of HBeAg-positive chronic hepatitis B, treatment should be continued until the&#xD;
      patient has achieved HBeAg seroconversion and undetectable serum HBV DNA and completed at&#xD;
      least 6 months of additional treatment after appearance of anti-HBe. Also several other&#xD;
      current guidelines of anti-viral treatment of chronic hepatitis B infection suggest that&#xD;
      nucleos (t) ide analogues treatment can be stopped following 6 to 12 months of consolidation&#xD;
      therapy after HBeAg seroconversion. However, there is a paucity of data available about the&#xD;
      long-term durability of Tenofovir induced HBeAg seroconversion as well as antiviral treatment&#xD;
      associated resistance risk.&#xD;
&#xD;
      2. Primary end points: HBeAg seroconversion was defined as loss of HBeAg with concurrent&#xD;
      appearance of HBeAb. Serological recurrence was defined as reappearance of HBeAg. Virological&#xD;
      recurrence was defined as an increase of HBV DNA level to greater than 10,000 copies/mL after&#xD;
      HBeAg seroconversion with previously HBV DNA levels less than 10,000 copies/mL.&#xD;
&#xD;
      3. Aims: To clarify the issue of adequate duration of consolidation period which could strike&#xD;
      a balance between durable HBeAg seroconversion and avoiding long-term inevitable serological&#xD;
      or virological recurrence.&#xD;
&#xD;
      4. Study design: A single-center cohort study which randomly allocating two different&#xD;
      extended TDF treatment periods after HBeAg seroconversion - 12 months, and 18 months across&#xD;
      patient groups. Then data will be collected about outcomes at a specific follow-up time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">April 18, 2018</completion_date>
  <primary_completion_date type="Actual">November 20, 2013</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>HBeAg seroconversion was defined as loss of HBeAg with concurrent appearance of HBeAb.</measure>
    <time_frame>3 years</time_frame>
    <description>We aim to clarify the issue of adequate duration of consolidation period which could strike a balance between durable HBeAg seroconversion and avoiding long-term inevitable serological or virological recurrence.</description>
  </primary_outcome>
  <enrollment type="Actual">137</enrollment>
  <condition>Hepatitis B</condition>
  <eligibility>
    <study_pop>
      <textblock>
        137 patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients with chronic HBV infection (HBsAg-positivity for at least six months&#xD;
             and HBeAg-positivity for at least three months) and serum HBV DNA levels ≥1000000&#xD;
             copies/ml (Cobas Amplicor HBV Monitor assay) at screening as well as serum ALT levels&#xD;
             &gt;1.3 times the ULN (43 IU/L) on at least two occasions in the previous 6 months and at&#xD;
             screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  co-infection with HCV, HDV, or HIV and treatment with (pegylated) interferon or other&#xD;
             nucleos (t) ide analogues for less than six months before the start of Tenofovir&#xD;
             treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chun-Hsiang Wang</name>
      <address>
        <city>Tainan</city>
        <zip>701</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 18, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>April 18, 2018</last_update_submitted>
  <last_update_submitted_qc>April 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatitis B virus, Tenofovir</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>
  </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/NCT01732354
org study id: IX-US-174-0206
nct id: NCT01732354
lead sponsor: 
has dmc: Yes
The investigators aim to clarify the issue of adequate duration of consolidation period of
      Chronic hepatitis B infection with antiviral treatment with Tenofovir which could strike a
      balance between durable HBeAg seroconversion and avoiding long-term inevitable serological or
      virological recurrence.
According to practice guidelines of American Association of the Study of Liver Diseases, in
      patients of HBeAg-positive chronic hepatitis B, treatment should be continued until the
      patient has achieved HBeAg seroconversion and undetectable serum HBV DNA and completed at
      least 6 months of additional treatment after appearance of anti-HBe. Also several other
      current guidelines of anti-viral treatment of chronic hepatitis B infection suggest that
      nucleos (t) ide analogues treatment can be stopped following 6 to 12 months of consolidation
      therapy after HBeAg seroconversion. However, there is a paucity of data available about the
      long-term durability of Tenofovir induced HBeAg seroconversion as well as antiviral treatment
      associated resistance risk.

      2. Primary end points: HBeAg seroconversion was defined as loss of HBeAg with concurrent
      appearance of HBeAb. Serological recurrence was defined as reappearance of HBeAg. Virological
      recurrence was defined as an increase of HBV DNA level to greater than 10,000 copies/mL after
      HBeAg seroconversion with previously HBV DNA levels less than 10,000 copies/mL.

      3. Aims: To clarify the issue of adequate duration of consolidation period which could strike
      a balance between durable HBeAg seroconversion and avoiding long-term inevitable serological
      or virological recurrence.

      4. Study design: A single-center cohort study which randomly allocating two different
      extended TDF treatment periods after HBeAg seroconversion - 12 months, and 18 months across
      patient groups. Then data will be collected about outcomes at a specific follow-up time.
observational model: Cohort
time perspective: Prospective
measure: HBeAg seroconversion was defined as loss of HBeAg with concurrent appearance of HBeAb.
time frame: 3 years
description: We aim to clarify the issue of adequate duration of consolidation period which could strike a balance between durable HBeAg seroconversion and avoiding long-term inevitable serological or virological recurrence.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis