<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/NCT01676597</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-HPS-01</org_study_id>
    <nct_id>NCT01676597</nct_id>
  </id_info>
  <brief_title>Efficacy of Pentoxifylline and Rifaximin Combination in Pentoxifylline Refractory Clinical and Subclinical Hepatopulmonary Syndrome</brief_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>
      -  The study will be a prospective open labelled double blinded randomized controlled&#xD;
           study.&#xD;
&#xD;
        -  The study will be conducted on patients admitted to Department of Hepatology from 2012&#xD;
           to 2014 at Institute of Liver and Biliary Sciences, New Delhi&#xD;
&#xD;
        -  Patients diagnosed as having clinical or subclinical hepatopulmonary syndrome will be&#xD;
           started on oral pentoxifylline therapy 400 mg thrice daily for 12 weeks.&#xD;
&#xD;
        -  Patients not responding to this therapy will be given divided into 2 arms with one arm&#xD;
           receiving additional Tab Rifaximin 400 mg thrice daily or placebo for 12 weeks.&#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>Complete response after 3 months of treatment</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Development of serious adverse effects leading to withdrawal of the drug</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Hepatopulmonary Syndrome</condition>
  <arm_group>
    <arm_group_label>rifaximin and pentoxifylline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pentoxifylline and placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pentoxifylline and rifaximin</intervention_name>
    <description>Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks</description>
    <arm_group_label>pentoxifylline and placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pentoxifylline and placebo</intervention_name>
    <description>Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks</description>
    <arm_group_label>rifaximin and pentoxifylline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Evidence of portal hypertension (esophagogastric varices or portal hypertensive&#xD;
             gastropathy identified on esophagogastroduodenoscopy, and/or varices seen on&#xD;
             computerized tomography scan or ultrasound, and/or splenomegaly with no other&#xD;
             explanation, and/or ascites with no other explanation)&#xD;
&#xD;
          2. Intrapulmonary vascular dilatations (IPVDs) diagnosed on contrast echocardiogram (CE)&#xD;
&#xD;
          3. AaDO2 &gt; 15 mm Hg on standing room air arterial blood gas (ABG)&#xD;
&#xD;
          4. Ability and willingness to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 or &gt; 64&#xD;
&#xD;
          -  Intrinsic significant cardiopulmonary disease&#xD;
&#xD;
          -  Inability to perform pulmonary function tests&#xD;
&#xD;
          -  Moderate to severe Pulmonary hypertension&#xD;
&#xD;
          -  Advanced hepatic encephalopathy&#xD;
&#xD;
          -  Inadequate echocardiographic window to allow for accurate transthoracic contrast&#xD;
             echocardiography&#xD;
&#xD;
          -  Antibiotic use within the last one month&#xD;
&#xD;
          -  Listed for liver transplant in next 4 weeks&#xD;
&#xD;
          -  Current use of exogenous nitrates&#xD;
&#xD;
          -  Active bacterial infections&#xD;
&#xD;
          -  Known malignancy&#xD;
&#xD;
          -  Known intolerance to Pentoxifylline or rifaximin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 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 Naveen, MD</last_name>
      <phone>011-46300000</phone>
      <email>naveenilbsdelhi@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Dr Ankit Bhardwaj</last_name>
      <phone>011-46300000</phone>
      <phone_ext>1032</phone_ext>
      <email>bhardwaj.ankit3@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 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>Hepatopulmonary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rifaximin</mesh_term>
    <mesh_term>Pentoxifylline</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/NCT01676597
org study id: ILBS-HPS-01
nct id: NCT01676597
lead sponsor: 
has dmc: No
-  The study will be a prospective open labelled double blinded randomized controlled
           study.

        -  The study will be conducted on patients admitted to Department of Hepatology from 2012
           to 2014 at Institute of Liver and Biliary Sciences, New Delhi

        -  Patients diagnosed as having clinical or subclinical hepatopulmonary syndrome will be
           started on oral pentoxifylline therapy 400 mg thrice daily for 12 weeks.

        -  Patients not responding to this therapy will be given divided into 2 arms with one arm
           receiving additional Tab Rifaximin 400 mg thrice daily or placebo for 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete response after 3 months of treatment
time frame: 3 months
measure: Development of serious adverse effects leading to withdrawal of the drug
time frame: 3 months
arm group label: rifaximin and pentoxifylline
arm group type: Experimental
description: Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks
arm group label: pentoxifylline and placebo
arm group type: Active Comparator
description: Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks
intervention type: Drug
intervention name: pentoxifylline and rifaximin
description: Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks
arm group label: pentoxifylline and placebo
intervention type: Drug
intervention name: Pentoxifylline and placebo
description: Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks
arm group label: rifaximin and pentoxifylline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 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: 
contact backup: 
country: India
responsible party type: Sponsor
mesh term: Hepatopulmonary Syndrome
mesh term: Syndrome
mesh term: Rifaximin
mesh term: Pentoxifylline