<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/NCT02238860</url>
  </required_header>
  <id_info>
    <org_study_id>AIMS-hep B-123</org_study_id>
    <nct_id>NCT02238860</nct_id>
  </id_info>
  <brief_title>A Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis</brief_title>
  <official_title>A Randomised Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asian Institute Of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asian Institute Of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents&#xD;
      have been claimed equivalent in treatment, there are no head to head trials available in the&#xD;
      literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed&#xD;
      to compare safety/efficacy and virological response in patients with HBV Decompensated&#xD;
      Cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effectiveness of entacavir and tenofovir has not been prospectively studied in HBV&#xD;
      Decompensated cirrhosis? This prospective, randomised clinical trial will help us in better&#xD;
      patient management more efficacy and cost effectiveness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2016</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and efficacy</measure>
    <time_frame>48 weeks</time_frame>
    <description>EFFICACY ENDPOINTS: EFFICACY ENDPOINTS INCLUDED PLASMA HBV DNA, ALT, HBEAG, HBSAG LOSS AND SEROCONVERION AS WELL AS CTP AND MELD SCORE.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>48 weeks</time_frame>
    <description>SAFETY ENDPOINTS: SAFETY ANALYSIS INCLUDED CUMALATIVE RATES ON TREATMENT ADVERSE EVENTS, SEREIOUS ADVERSE EFFECTS DISCONTINUATION DUE TO SIDE EFFECTS,DEATH,HCC,RENAL IMPAIRMENT , HEPATIC FLARE AND DEVELOPMENT OF DRUG RESISTANCE.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Outcome</measure>
    <time_frame>48 weeks</time_frame>
    <description>Death</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cirrhosis Due to Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Entacavir</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Entacavir 0.5 mg (OD) for 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tenofovir</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tenofovir 300 mg ,OD for 48 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Entacavir</intervention_name>
    <description>Entacavir-0.5 mg ,OD,for</description>
    <arm_group_label>Entacavir</arm_group_label>
    <arm_group_label>Tenofovir</arm_group_label>
    <other_name>ETV</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir</intervention_name>
    <description>Tenofovir ,300 mg,OD,for 48 weeks</description>
    <arm_group_label>Entacavir</arm_group_label>
    <arm_group_label>Tenofovir</arm_group_label>
    <other_name>TDF or PMPA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age (18 years- 70 years)&#xD;
&#xD;
          -  Hbv surface antigen positive &gt; 6 months&#xD;
&#xD;
          -  HbeAg (positive or negative both)&#xD;
&#xD;
          -  Hbv DNA 10^3&#xD;
&#xD;
          -  ALT ULN&#xD;
&#xD;
          -  No evidence of HCC&#xD;
&#xD;
          -  Platelets count &gt; 30 thousands&#xD;
&#xD;
          -  CTP score &gt; 7&#xD;
&#xD;
          -  Hepatic encephalopathy (grade 1 - 2 only)&#xD;
&#xD;
          -  No prior Drug resistance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  HCC patients&#xD;
&#xD;
          -  Prior drug resistance&#xD;
&#xD;
          -  Current HE &gt; 2&#xD;
&#xD;
          -  Solid organ transplantation&#xD;
&#xD;
          -  Inadequate hematological function&#xD;
&#xD;
          -  Co infection with hepatitis C and HIV&#xD;
&#xD;
          -  Autoimmune disorders&#xD;
&#xD;
          -  Pregnancy and Breast feeding&#xD;
&#xD;
          -  Other hepatic diseases&#xD;
&#xD;
          -  Patients on immunosuppressant or chemotherapy agents&#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>Mohammad sadik Memon, Fcps gastro</last_name>
    <role>Principal Investigator</role>
    <affiliation>AIMS Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dr mohammad sadik Memon, Fcps gastro</last_name>
    <phone>022-232593</phone>
    <email>Sadikmemon@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Madiha Zaki, MSC gastro</last_name>
    <phone>022-232593</phone>
    <email>Madiyaah@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Asian Institute of medical Sciences</name>
      <address>
        <city>Hyderabad</city>
        <state>Sindh</state>
        <zip>71800</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr mohammad sadik Memon, FCPS gastro</last_name>
      <phone>022-232593</phone>
      <email>Sadikmemon@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Dr sadik Memon, FCPS gastro</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dr Madiha Zaki, MSC gastro</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dr NANDLAL Serani, FCPS gastro</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dr Umar Soomro, MBBS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asian Institute Of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Mohammad sadik memon</investigator_full_name>
    <investigator_title>Professor of gastroenterology</investigator_title>
  </responsible_party>
  <keyword>Hepatitis B</keyword>
  <keyword>cirrhosis</keyword>
  <keyword>Entacavir</keyword>
  <keyword>enofovir</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>
    <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>Tenofovir</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/NCT02238860
org study id: AIMS-hep B-123
nct id: NCT02238860
lead sponsor: 
has dmc: No
Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents
      have been claimed equivalent in treatment, there are no head to head trials available in the
      literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed
      to compare safety/efficacy and virological response in patients with HBV Decompensated
      Cirrhosis.
The effectiveness of entacavir and tenofovir has not been prospectively studied in HBV
      Decompensated cirrhosis? This prospective, randomised clinical trial will help us in better
      patient management more efficacy and cost effectiveness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Safety and efficacy
time frame: 48 weeks
description: EFFICACY ENDPOINTS: EFFICACY ENDPOINTS INCLUDED PLASMA HBV DNA, ALT, HBEAG, HBSAG LOSS AND SEROCONVERION AS WELL AS CTP AND MELD SCORE.
measure: Safety
time frame: 48 weeks
description: SAFETY ENDPOINTS: SAFETY ANALYSIS INCLUDED CUMALATIVE RATES ON TREATMENT ADVERSE EVENTS, SEREIOUS ADVERSE EFFECTS DISCONTINUATION DUE TO SIDE EFFECTS,DEATH,HCC,RENAL IMPAIRMENT , HEPATIC FLARE AND DEVELOPMENT OF DRUG RESISTANCE.
measure: Outcome
time frame: 48 weeks
description: Death
arm group label: Entacavir
arm group type: Active Comparator
description: Entacavir 0.5 mg (OD) for 48 weeks
arm group label: Tenofovir
arm group type: Active Comparator
description: Tenofovir 300 mg ,OD for 48 weeks
intervention type: Drug
intervention name: Entacavir
description: Entacavir-0.5 mg ,OD,for
arm group label: Entacavir
arm group label: Tenofovir
other name: ETV
intervention type: Drug
intervention name: Tenofovir
description: Tenofovir ,300 mg,OD,for 48 weeks
arm group label: Entacavir
arm group label: Tenofovir
other name: TDF or PMPA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Mohammad sadik Memon, Fcps gastro
role: Principal Investigator
affiliation: AIMS Institute
last name: Dr mohammad sadik Memon, Fcps gastro
phone: 022-232593
email: Sadikmemon@gmail.com
last name: Madiha Zaki, MSC gastro
phone: 022-232593
email: Madiyaah@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Asian Institute Of Medical Sciences
investigator full name: Mohammad sadik memon
investigator title: Professor of gastroenterology
mesh term: Hepatitis B
mesh term: Hepatitis
mesh term: Liver Cirrhosis
mesh term: Fibrosis
mesh term: Tenofovir