<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/NCT01677871</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-ATT-01</org_study_id>
    <nct_id>NCT01677871</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease</brief_title>
  <official_title>Study of Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease</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>
      During the Study:&#xD;
&#xD;
        -  Subject is required to visit every week for the first 2 months and then every month till&#xD;
           completion of study or as and when required&#xD;
&#xD;
        -  The usual symptomatic and supportive treatment of Chronic Liver Disease, including use&#xD;
           of antiviral, will be given to all patients.&#xD;
&#xD;
        -  Effort will be made to avoid use of other hepatotoxic drug(s) during Anti-Tubercular&#xD;
           Treatment.&#xD;
&#xD;
        -  Liver function tests (LFT) will be done weekly during first 2 months then at one month&#xD;
           interval or as when required.&#xD;
&#xD;
        -  The treatment efficacy of Anti-Tubercular Treatment (ATT) will be made on the basis of&#xD;
           clinical, biochemical, microbiological and imaging parameters at months 2, 4, 7 and 9.&#xD;
           Patients not improving at 4 weeks after initiation of treatment will be shifted to&#xD;
           alternative regimens and will be excluded from the study.&#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">September 2014</completion_date>
  <primary_completion_date type="Anticipated">September 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>Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen.</measure>
    <time_frame>6 and 9 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Worsening of CTP (CHILD TURCOTTE PUGH) score to ≥10 for patients with compensated cirrhosis,</measure>
    <time_frame>6 and 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Failure to re-institute the assigned ATT (ANTI TUBERCULAR TREATMENT) regimen after development of an episode of hepatotoxicity. (I.e. second episode of hepatotoxicity.</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>6 and 9 months</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Chronic Liver Disease With Tuberclosis</condition>
  <arm_group>
    <arm_group_label>2HRZE/4HR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2HRLE/4HR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>9HLE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Isoniazid+ Levofloxacin+ Ethambutol for 9 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>9RLE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rifampicin + Levofloxacin+ Ethambutol for 9 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2HRZE/4HR</intervention_name>
    <description>Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months</description>
    <arm_group_label>2HRLE/4HR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2HRLE/4HR</intervention_name>
    <description>Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months</description>
    <arm_group_label>2HRZE/4HR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>9HLE</intervention_name>
    <description>Isoniazid+ Levofloxacin+ Ethambutol for 9 months</description>
    <arm_group_label>9RLE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>9RLE</intervention_name>
    <description>Rifampicin + Levofloxacin+ Ethambutol for 9 months</description>
    <arm_group_label>9HLE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or Females subjects aged 18-75 years.&#xD;
&#xD;
          -  Subjects with chronic liver disease (cirrhosis)&#xD;
&#xD;
          -  Pulmonary or extra-pulmonary tuberculosis.&#xD;
&#xD;
          -  Serum ALT≤5times upper limit and serum bilirubin ≤3 mg/dl.&#xD;
&#xD;
          -  consent and willingness to follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serum ALT&gt;5times upper limit and serum bilirubin &gt;3 mg/dl.&#xD;
&#xD;
          -  Renal failure (serum creatinine&gt;2mg/dl).&#xD;
&#xD;
          -  Presence of hepatocellular carcinoma&#xD;
&#xD;
          -  Alcoholic cirrhotic who continue to drink alcohol.&#xD;
&#xD;
          -  Prior history of ATT (ANTI TUBERCULAR TREATMENT) with documented hepatotoxicity.&#xD;
&#xD;
          -  Known hypersensitivity to levofloxacin, other quinolones&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Naveen Kumar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Liver and Biliary Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dr Naveen Kumar, MD</last_name>
    <phone>011-46300000</phone>
    <email>naveenilbsdelhi@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dr Ankit Bhardwaj</last_name>
    <phone>011-46300000</phone>
    <phone_ext>1032</phone_ext>
    <email>bhardwaj.ankit3@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institute of Liver and Biliary Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr Ankit Bhardwaj</last_name>
      <phone>011-46300000</phone>
      <email>bhardwaj.ankit3@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>December 16, 2013</last_update_submitted>
  <last_update_submitted_qc>December 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 17, 2013</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>Tuberculosis</mesh_term>
    <mesh_term>Liver Diseases</mesh_term>
  </condition_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/NCT01677871
org study id: ILBS-ATT-01
nct id: NCT01677871
lead sponsor: 
has dmc: No
During the Study:

        -  Subject is required to visit every week for the first 2 months and then every month till
           completion of study or as and when required

        -  The usual symptomatic and supportive treatment of Chronic Liver Disease, including use
           of antiviral, will be given to all patients.

        -  Effort will be made to avoid use of other hepatotoxic drug(s) during Anti-Tubercular
           Treatment.

        -  Liver function tests (LFT) will be done weekly during first 2 months then at one month
           interval or as when required.

        -  The treatment efficacy of Anti-Tubercular Treatment (ATT) will be made on the basis of
           clinical, biochemical, microbiological and imaging parameters at months 2, 4, 7 and 9.
           Patients not improving at 4 weeks after initiation of treatment will be shifted to
           alternative regimens and will be excluded from the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen.
time frame: 6 and 9 months
measure: Worsening of CTP (CHILD TURCOTTE PUGH) score to ≥10 for patients with compensated cirrhosis,
time frame: 6 and 9 months
measure: Failure to re-institute the assigned ATT (ANTI TUBERCULAR TREATMENT) regimen after development of an episode of hepatotoxicity. (I.e. second episode of hepatotoxicity.
measure: Survival
time frame: 6 and 9 months
arm group label: 2HRZE/4HR
arm group type: Experimental
description: Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months
arm group label: 2HRLE/4HR
arm group type: Active Comparator
description: Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months
arm group label: 9HLE
arm group type: Experimental
description: Isoniazid+ Levofloxacin+ Ethambutol for 9 months
arm group label: 9RLE
arm group type: Active Comparator
description: Rifampicin + Levofloxacin+ Ethambutol for 9 months
intervention type: Drug
intervention name: 2HRZE/4HR
description: Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months
arm group label: 2HRLE/4HR
intervention type: Drug
intervention name: 2HRLE/4HR
description: Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months
arm group label: 2HRZE/4HR
intervention type: Drug
intervention name: 9HLE
description: Isoniazid+ Levofloxacin+ Ethambutol for 9 months
arm group label: 9RLE
intervention type: Drug
intervention name: 9RLE
description: Rifampicin + Levofloxacin+ Ethambutol for 9 months
arm group label: 9HLE
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Dr Naveen Kumar, MD
role: Principal Investigator
affiliation: Institute of Liver and Biliary Sciences
last name: Dr Naveen Kumar, MD
phone: 011-46300000
email: naveenilbsdelhi@gmail.com
last name: Dr Ankit Bhardwaj
phone: 011-46300000
phone ext: 1032
email: bhardwaj.ankit3@gmail.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Liver Diseases