<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/NCT01720238</url>
  </required_header>
  <id_info>
    <org_study_id>D1211000039120003</org_study_id>
    <nct_id>NCT01720238</nct_id>
  </id_info>
  <brief_title>Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis</brief_title>
  <official_title>Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing YouAn Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Ditan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing 302 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Friendship Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Though newly reported HBV infection and HBsAg prevalence in China have greatly decreased,&#xD;
      patients who had been chronically infected with HBV, especially those with liver cirrhosis&#xD;
      cause great burden on public health care. In view of economic development level, drug&#xD;
      availability and lack of independent health economics evidence, the investigators are still&#xD;
      unable to give specific guidelines for HBV related compensated liver cirrhosis in China.&#xD;
      Therefore, the investigators aim to investigate clinical effects and cost-effectiveness of&#xD;
      two early anti-viral therapy strategies on HBV related compensated liver cirrhosis through&#xD;
      this prospective, open-label, multicenter and nonrandomized study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>Decompensation rate of liver cirrhosis</measure>
    <time_frame>3 years</time_frame>
    <description>presence of ascites, variceal hemorrhage, hepatic encephalopathy and HCC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>child-pugh score</measure>
    <time_frame>1,2 and 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HBVDNA undetected</measure>
    <time_frame>1,2 and 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>liver elasticity</measure>
    <time_frame>1, 2, and 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>life quality score</measure>
    <time_frame>1, 2 and 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cost-effectiveness</measure>
    <time_frame>1, 2 and 3 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">621</enrollment>
  <condition>Liver Cirrhosis</condition>
  <condition>Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Entecavir Therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Lamivudine plus Adefovir Dipivoxil Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Entecavir</intervention_name>
    <description>0.5mg qd</description>
    <arm_group_label>Group 1</arm_group_label>
    <other_name>Baraclude</other_name>
    <other_name>other manufacturers</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lamivudine plus Adefovir Dipivoxil</intervention_name>
    <description>Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd</description>
    <arm_group_label>Group 2</arm_group_label>
    <other_name>Heptodin</other_name>
    <other_name>other manufactures</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum,plasma and DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        compensated HBV Related liver cirrhosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  aged 18-70 years&#xD;
&#xD;
          -  clinical diagnosis of compensated liver cirrhosis&#xD;
&#xD;
               1. liver biopsy showing cirrhosis&#xD;
&#xD;
               2. endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension&#xD;
&#xD;
               3. if no biopsy or endoscopy ，should meet two of the four:&#xD;
&#xD;
                    -  Imaging(US, CT or MRI, et al) showing Surface nodularity： Echogenecity&#xD;
                       （spleen pachydiameter &gt; 4.0cm or&gt; 5 costal region）&#xD;
&#xD;
                         -  PLT &lt; 100×10 &lt; 9 &gt;/L，no other interpretation&#xD;
&#xD;
                              -  ALB &lt; 35.0 g/L, or INR &gt; 1.3, or CHE &lt; 5.0KU/L&#xD;
&#xD;
                                   -  Liver stiffness measurement value &gt; 12.4 kpa&#xD;
&#xD;
          -  HBeAg(+)with HBVDNA &gt; 10 &lt; 3 &gt; IU/mL or HBeAg(-) wtih HBVDNA &gt; 102 IU/mL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient with decompensated liver cirrhosis:presence of ascites, variceal&#xD;
             hemorrhage,hepatic encephalopathy&#xD;
&#xD;
          -  allergic to any ingredients of the drugs&#xD;
&#xD;
          -  patient complicated with alcoholic liver disease, autoimmune liver disease, heretic&#xD;
             liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic&#xD;
             liver disease.&#xD;
&#xD;
          -  AFP &gt; 100ng/ml or Cr &gt; 1.5×ULN&#xD;
&#xD;
          -  pregnant woman&#xD;
&#xD;
          -  patient with severe disease or other organ failure&#xD;
&#xD;
          -  patient with any tumors&#xD;
&#xD;
          -  patient with sever mental disease.&#xD;
&#xD;
          -  patients with any disease or condition which the investigator or treating physician&#xD;
             feels would interfere with the trial or the safety of the subject&#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>Dong Ji Jia, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing 302 Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Ditan Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Tiantan Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing YouAn Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PeKing University People's Hopital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Peking University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>July 27, 2015</last_update_submitted>
  <last_update_submitted_qc>July 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Jia Ji-Dong</investigator_full_name>
    <investigator_title>Director of Liver Research Center</investigator_title>
  </responsible_party>
  <keyword>Compensated Liver Cirrhosis</keyword>
  <keyword>Early Antiviral Therapy</keyword>
  <keyword>Cost Effectiveness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis B</mesh_term>
    <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>Adefovir dipivoxil</mesh_term>
    <mesh_term>Entecavir</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/NCT01720238
org study id: D1211000039120003
nct id: NCT01720238
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Though newly reported HBV infection and HBsAg prevalence in China have greatly decreased,
      patients who had been chronically infected with HBV, especially those with liver cirrhosis
      cause great burden on public health care. In view of economic development level, drug
      availability and lack of independent health economics evidence, the investigators are still
      unable to give specific guidelines for HBV related compensated liver cirrhosis in China.
      Therefore, the investigators aim to investigate clinical effects and cost-effectiveness of
      two early anti-viral therapy strategies on HBV related compensated liver cirrhosis through
      this prospective, open-label, multicenter and nonrandomized study.
observational model: Cohort
time perspective: Prospective
measure: Decompensation rate of liver cirrhosis
time frame: 3 years
description: presence of ascites, variceal hemorrhage, hepatic encephalopathy and HCC
measure: child-pugh score
time frame: 1,2 and 3 years
measure: HBVDNA undetected
time frame: 1,2 and 3 years
measure: liver elasticity
time frame: 1, 2, and 3 years
measure: life quality score
time frame: 1, 2 and 3 years
measure: cost-effectiveness
time frame: 1, 2 and 3 years
arm group label: Group 1
description: Entecavir Therapy
arm group label: Group 2
description: Lamivudine plus Adefovir Dipivoxil Therapy
intervention type: Drug
intervention name: Entecavir
description: 0.5mg qd
arm group label: Group 1
other name: Baraclude
other name: other manufacturers
intervention type: Drug
intervention name: Lamivudine plus Adefovir Dipivoxil
description: Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd
arm group label: Group 2
other name: Heptodin
other name: other manufactures
serum,plasma and DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Dong Ji Jia, Doctor
role: Principal Investigator
affiliation: Beijing Friendship Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Friendship Hospital
investigator full name: Jia Ji-Dong
investigator title: Director of Liver Research Center
mesh term: Hepatitis B
mesh term: Liver Cirrhosis
mesh term: Fibrosis
mesh term: Lamivudine
mesh term: Adefovir
mesh term: Adefovir dipivoxil
mesh term: Entecavir