<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/NCT01698723</url>
  </required_header>
  <id_info>
    <org_study_id>HEV-RIBA</org_study_id>
    <nct_id>NCT01698723</nct_id>
  </id_info>
  <brief_title>A Trial of Ribavirin in Patients With ACLF Due to Hepatitis E Virus</brief_title>
  <acronym>HEVRibavirin</acronym>
  <official_title>A Double Blind Placebo Controlled Randomized Trial of Ribavirin in Patients With Acute on Chronic Liver Failure Due to Hepatitis E Virus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>All India Institute of Medical Sciences, New Delhi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>All India Institute of Medical Sciences, New Delhi</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The term Acute on chronic liver failure (ACLF) describes a clinical entity characterized by&#xD;
      an acute and rapid deterioration of liver function in a patient with previously&#xD;
      well-compensated liver disease owing to the effects of a precipitating event. In this&#xD;
      condition two insults act simultaneously, one being the preexisting liver injury (chronic&#xD;
      liver disease) and the other acute injury which is responsible for the acute decompensation.&#xD;
      HEV being a major factor responsible for this clinical entity and has a very high mortality&#xD;
      rate. Ribavirin being a safe drug and has been shown to inhibit the replication of HEV, can&#xD;
      be an important drug in the treatment of these patients. Therefore the present study is&#xD;
      designed to study the impact of Ribavirin in reducing the mortality due to HEV related ACLF.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in survival</measure>
    <time_frame>4 weeks and 12 moths</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child Score</measure>
    <time_frame>4 weeks and 12 months</time_frame>
    <description>Change in Child Score will be evaluated at every 4 week interval</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viremia</measure>
    <time_frame>4 weeks, 3 months</time_frame>
    <description>Change in viral load</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variceal bleeding</measure>
    <time_frame>4 weeks and 12 months</time_frame>
    <description>Variceal bleeding will be assessed every 4 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Acute on Chronic Hepatic Failure</condition>
  <condition>Liver Failure</condition>
  <condition>Hepatitis E Infection</condition>
  <arm_group>
    <arm_group_label>Ribavirin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1000 mg (5 capsules)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>5 capsules of placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin</intervention_name>
    <arm_group_label>Ribavirin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All ACLF due to HEV&#xD;
&#xD;
          -  Consent to participate in trial and collection of blood.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant and nursing mothers.&#xD;
&#xD;
          -  Severe anemia&#xD;
&#xD;
          -  Other etiologies of ACLF (eg. Alcohol, drugs, reactivation of hepatitis B and&#xD;
             hepatitis C, variceal bleeding, surgical intervention and sepsis)&#xD;
&#xD;
          -  Hepatocellular carcinoma (HCC)&#xD;
&#xD;
          -  Hepatorenal syndrome (HRS) at admission&#xD;
&#xD;
          -  Presence of life threatening cardiovascular, respiratory and neurological disease&#xD;
&#xD;
          -  Acquired Immunodeficiency Syndrome&#xD;
&#xD;
          -  Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)&#xD;
&#xD;
          -  Refusal to provide consent to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Subrat K Acharya, DM</last_name>
    <role>Principal Investigator</role>
    <affiliation>All India Institute of Medical Sciences, New Delhi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Subrat K Acharya, DM</last_name>
    <phone>+91-11-26594934</phone>
    <email>subratacharya2004@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shalimar ., DM</last_name>
    <phone>+919968405815</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>AII India Institute of Medical Sciences</name>
      <address>
        <city>Delhi</city>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Subrat K Acharya, DM</last_name>
      <phone>+91-11-26594934</phone>
      <email>subratacharya2004@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Shalimar ., DM</last_name>
      <phone>+91-9968405815</phone>
      <email>drshalimar@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Subrat K Acharya, DM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>All India Institute of Medical Sciences</name>
      <address>
        <city>Delhi</city>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Subrat K Acharya, DM</last_name>
      <phone>+91-11-26594934</phone>
      <email>subratacharya2004@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Shalimar ., DM</last_name>
      <phone>+91-9968405815</phone>
      <email>drshalimar@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Subrat K Acharya, DM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>April 24, 2016</last_update_submitted>
  <last_update_submitted_qc>April 24, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>All India Institute of Medical Sciences, New Delhi</investigator_affiliation>
    <investigator_full_name>Subrat Kumar Acharya</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>ACLF</keyword>
  <keyword>HEV</keyword>
  <keyword>Ribavirin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis E</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Liver Failure</mesh_term>
    <mesh_term>Hepatic Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01698723
org study id: HEV-RIBA
nct id: NCT01698723
lead sponsor: 
has dmc: Yes
The term Acute on chronic liver failure (ACLF) describes a clinical entity characterized by
      an acute and rapid deterioration of liver function in a patient with previously
      well-compensated liver disease owing to the effects of a precipitating event. In this
      condition two insults act simultaneously, one being the preexisting liver injury (chronic
      liver disease) and the other acute injury which is responsible for the acute decompensation.
      HEV being a major factor responsible for this clinical entity and has a very high mortality
      rate. Ribavirin being a safe drug and has been shown to inhibit the replication of HEV, can
      be an important drug in the treatment of these patients. Therefore the present study is
      designed to study the impact of Ribavirin in reducing the mortality due to HEV related ACLF.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Improvement in survival
time frame: 4 weeks and 12 moths
measure: Child Score
time frame: 4 weeks and 12 months
description: Change in Child Score will be evaluated at every 4 week interval
measure: Viremia
time frame: 4 weeks, 3 months
description: Change in viral load
measure: Variceal bleeding
time frame: 4 weeks and 12 months
description: Variceal bleeding will be assessed every 4 weeks
arm group label: Ribavirin
arm group type: Active Comparator
description: 1000 mg (5 capsules)
arm group label: Placebo
arm group type: Placebo Comparator
description: 5 capsules of placebo
intervention type: Drug
intervention name: Ribavirin
arm group label: Ribavirin
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Subrat K Acharya, DM
role: Principal Investigator
affiliation: All India Institute of Medical Sciences, New Delhi
last name: Subrat K Acharya, DM
phone: +91-11-26594934
email: subratacharya2004@yahoo.com
last name: Shalimar ., DM
phone: +919968405815
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: India
responsible party type: Principal Investigator
investigator affiliation: All India Institute of Medical Sciences, New Delhi
investigator full name: Subrat Kumar Acharya
investigator title: Professor
mesh term: Hepatitis A
mesh term: Hepatitis E
mesh term: Hepatitis
mesh term: Liver Failure
mesh term: Hepatic Insufficiency
mesh term: Ribavirin
sharing ipd: Yes