<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/NCT01693679</url>
  </required_header>
  <id_info>
    <org_study_id>Telbivudine</org_study_id>
    <nct_id>NCT01693679</nct_id>
  </id_info>
  <brief_title>Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shao-quan Zhang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      • To estimate renoprotective efficacy of Telbivudine treated patients with HBV-related liver&#xD;
      cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <primary_completion_date type="Anticipated">April 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks</measure>
    <time_frame>May 2014</time_frame>
    <description>No.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in ALT normalization rate,• The rate of complications,• Percentage of participants with HBeAg loss &amp; HBeAg seroconversion and Percentage of subjects achieving HBV DNA&lt;300copies/mL at96 weeks</measure>
    <time_frame>May 2014</time_frame>
    <description>No.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>HBV-related Liver Cirrhosis</condition>
  <arm_group>
    <arm_group_label>antiviral drug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telbivudine team,Telbivudine,600mg/d,oral,60 patients. non-Tebivudine team,Lamivudine,100mg/d,oral,20 patients.Adefovir,10mg/d,oral,20 patients.Enecavir,0.5mg/d,oral,20 patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telbivudine, Lamivudine, Adefovir ,Enecavir</intervention_name>
    <description>investigational Telbivudine,600mg,daily,oral.comparator Lamivudine,100mg daily, oral,Adefovir,10mg,daily,oral,Enecavir,0.5mg,daily,oral.</description>
    <arm_group_label>antiviral drug</arm_group_label>
    <other_name>no.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects eligible for enrolment in the study must meet all of the following criteria:&#xD;
&#xD;
          -  Aged between 18-75 years (inclusive).&#xD;
&#xD;
          -  Male or female.&#xD;
&#xD;
          -  Subjects with positive HBsAg for more than 6 months and anti-HBs negative regardless&#xD;
             of HBeAg status , HBV DNA ≥2×103 IU/ml&#xD;
&#xD;
          -  Subjects with HBV-related liver cirrhosis, including compensated cirrhosis and&#xD;
             decompensated, but only Child-Pugh A or B.&#xD;
&#xD;
          -  The ablility to understand and sign a written informed consent prior to any study&#xD;
             related procedure and comply with the requirements of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects meeting any of the following criteria must not be enrolled in the study&#xD;
&#xD;
               -  Subjects with non-HBV cirrhosis&#xD;
&#xD;
               -  Co-infection with HAV/HCV/HDV/ HIV&#xD;
&#xD;
               -  Subjects who take nucleosides within 6 months&#xD;
&#xD;
               -  Kidney injury due to non-HBV factors&#xD;
&#xD;
               -  Inability to comply with study requirements as determined by the study&#xD;
                  investigator&#xD;
&#xD;
               -  Patients with very low GFR, who may need dialysis or renal transplantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 24, 2012</last_update_submitted>
  <last_update_submitted_qc>September 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Shao-quan Zhang</investigator_full_name>
    <investigator_title>Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University</investigator_title>
  </responsible_party>
  <keyword>Tebivudine eGFR non-Tebivudine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lamivudine</mesh_term>
    <mesh_term>Adefovir</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/NCT01693679
org study id: Telbivudine
nct id: NCT01693679
lead sponsor: 
has dmc: Yes
• To estimate renoprotective efficacy of Telbivudine treated patients with HBV-related liver
      cirrhosis.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks
time frame: May 2014
description: No.
measure: Change from Baseline in ALT normalization rate,• The rate of complications,• Percentage of participants with HBeAg loss & HBeAg seroconversion and Percentage of subjects achieving HBV DNA<300copies/mL at96 weeks
time frame: May 2014
description: No.
arm group label: antiviral drug
arm group type: Experimental
description: Telbivudine team,Telbivudine,600mg/d,oral,60 patients. non-Tebivudine team,Lamivudine,100mg/d,oral,20 patients.Adefovir,10mg/d,oral,20 patients.Enecavir,0.5mg/d,oral,20 patients.
intervention type: Drug
intervention name: Telbivudine, Lamivudine, Adefovir ,Enecavir
description: investigational Telbivudine,600mg,daily,oral.comparator Lamivudine,100mg daily, oral,Adefovir,10mg,daily,oral,Enecavir,0.5mg,daily,oral.
arm group label: antiviral drug
other name: no.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Shao-quan Zhang
investigator title: Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University
mesh term: Liver Cirrhosis
mesh term: Fibrosis
mesh term: Lamivudine
mesh term: Adefovir
mesh term: Telbivudine