<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/NCT01732224</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-HBV Reactivation-01</org_study_id>
    <nct_id>NCT01732224</nct_id>
  </id_info>
  <brief_title>To Compare the Efficacy of Combined Tenofovir Plus Telbivudine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B</brief_title>
  <official_title>A Prospective Randomized Controlled Study to Compare the Efficacy of Combined Tenofovir Plus Telbuvidine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The relevant data will be prospectively collected included patient demographics, clinical,&#xD;
      all laboratory variables including virological tests, genotyping by direct sequencing,&#xD;
      abdominal ultrasound, and upper gastrointestinal (GI) endoscopy. Trans jugular liver biopsy&#xD;
      (TJLB) and hepatic venous pressure gradient (HVPG) will be done in patients when it was not&#xD;
      evident whether the underlying liver disease was chronic based on clinical, biochemical,&#xD;
      radiological investigations, and upper GI endoscopy. Severity of the liver disease will be&#xD;
      assessed by Child-Turcotte Pugh score (CTP) and model for end stage liver disease (MELD)&#xD;
      score.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>1 and 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in HBV DNA.</measure>
    <time_frame>7 days, 15 days, 1 month and 3 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug(s) related adverse effects/ side effects</measure>
    <time_frame>1 and 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in CTP and MELD scores</measure>
    <time_frame>1 and 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alteration of renal functions</measure>
    <time_frame>1 and 3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Spontaneous Reactivation of Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Tenofovir + Telbivudine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tenofovir (300 mg/day) plus telbivudine (600 mg/day).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tenofovir</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In tenofovir arm subjects will receive tenofovir (300 mg) once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir + Telbivudine</intervention_name>
    <description>Tenofovir (300 mg/day) plus telbivudine (600 mg/day).</description>
    <arm_group_label>Tenofovir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir</intervention_name>
    <description>In tenofovir arm subjects will receive tenofovir (300 mg) once daily.</description>
    <arm_group_label>Tenofovir + Telbivudine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Reactivation of CHB characterized by a rise in ALT level &gt;5 times upper limit of&#xD;
             normal along with HBV DNA level &gt;10^5 copies/ mL (&gt; 1.8 X 10^4 IU/mL).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Superinfection with other viruses (hepatitis E, A, D, or C)&#xD;
&#xD;
          2. other causes of chronic liver failure&#xD;
&#xD;
          3. coexistent hepatocellular carcinoma (HCC)&#xD;
&#xD;
          4. portal vein thrombosis&#xD;
&#xD;
          5. coexistent renal impairment&#xD;
&#xD;
          6. pregnancy&#xD;
&#xD;
          7. coinfection with human immunodeficiency virus (HIV)&#xD;
&#xD;
          8. patients who had received a previous course of any antiviral, immunomodulator or&#xD;
             cytotoxic/immunosuppressive therapy for chronic hepatitis or other illness within at&#xD;
             least the preceding 12 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shiv Kumar Sarin, DM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Liver &amp; Biliary Sciences (ILBS).</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Liver &amp; Biliary Sciences (ILBS)</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 19, 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>March 22, 2016</last_update_submitted>
  <last_update_submitted_qc>March 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Telbivudine</mesh_term>
  </intervention_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/NCT01732224
org study id: ILBS-HBV Reactivation-01
nct id: NCT01732224
lead sponsor: 
has dmc: No
The relevant data will be prospectively collected included patient demographics, clinical,
      all laboratory variables including virological tests, genotyping by direct sequencing,
      abdominal ultrasound, and upper gastrointestinal (GI) endoscopy. Trans jugular liver biopsy
      (TJLB) and hepatic venous pressure gradient (HVPG) will be done in patients when it was not
      evident whether the underlying liver disease was chronic based on clinical, biochemical,
      radiological investigations, and upper GI endoscopy. Severity of the liver disease will be
      assessed by Child-Turcotte Pugh score (CTP) and model for end stage liver disease (MELD)
      score.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival
time frame: 1 and 3 months
measure: Reduction in HBV DNA.
time frame: 7 days, 15 days, 1 month and 3 month
measure: Drug(s) related adverse effects/ side effects
time frame: 1 and 3 months
measure: Improvement in CTP and MELD scores
time frame: 1 and 3 months
measure: Alteration of renal functions
time frame: 1 and 3 months
arm group label: Tenofovir + Telbivudine
arm group type: Experimental
description: Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
arm group label: Tenofovir
arm group type: Active Comparator
description: In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
intervention type: Drug
intervention name: Tenofovir + Telbivudine
description: Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
arm group label: Tenofovir
intervention type: Drug
intervention name: Tenofovir
description: In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
arm group label: Tenofovir + Telbivudine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Shiv Kumar Sarin, DM
role: Principal Investigator
affiliation: Institute of Liver & Biliary Sciences (ILBS).
facility: 
country: India
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis
mesh term: Tenofovir
mesh term: Telbivudine