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Efficacy of Pentoxifylline and Rifaximin Combination in Pentoxifylline Refractory Clinical and Subclinical Hepatopulmonary Syndrome

Primary Purpose

Hepatopulmonary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
pentoxifylline and rifaximin
Pentoxifylline and placebo
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatopulmonary Syndrome

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Evidence of portal hypertension (esophagogastric varices or portal hypertensive gastropathy identified on esophagogastroduodenoscopy, and/or varices seen on computerized tomography scan or ultrasound, and/or splenomegaly with no other explanation, and/or ascites with no other explanation)
  2. Intrapulmonary vascular dilatations (IPVDs) diagnosed on contrast echocardiogram (CE)
  3. AaDO2 > 15 mm Hg on standing room air arterial blood gas (ABG)
  4. Ability and willingness to give informed consent

Exclusion Criteria:

  • Age < 18 or > 64
  • Intrinsic significant cardiopulmonary disease
  • Inability to perform pulmonary function tests
  • Moderate to severe Pulmonary hypertension
  • Advanced hepatic encephalopathy
  • Inadequate echocardiographic window to allow for accurate transthoracic contrast echocardiography
  • Antibiotic use within the last one month
  • Listed for liver transplant in next 4 weeks
  • Current use of exogenous nitrates
  • Active bacterial infections
  • Known malignancy
  • Known intolerance to Pentoxifylline or rifaximin

Sites / Locations

  • Institute of Liver and Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rifaximin and pentoxifylline

pentoxifylline and placebo

Arm Description

Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks

Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks

Outcomes

Primary Outcome Measures

Complete response after 3 months of treatment

Secondary Outcome Measures

Development of serious adverse effects leading to withdrawal of the drug

Full Information

First Posted
August 29, 2012
Last Updated
December 16, 2013
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT01676597
Brief Title
Efficacy of Pentoxifylline and Rifaximin Combination in Pentoxifylline Refractory Clinical and Subclinical Hepatopulmonary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatopulmonary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rifaximin and pentoxifylline
Arm Type
Experimental
Arm Description
Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks
Arm Title
pentoxifylline and placebo
Arm Type
Active Comparator
Arm Description
Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
pentoxifylline and rifaximin
Intervention Description
Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline and placebo
Intervention Description
Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks
Primary Outcome Measure Information:
Title
Complete response after 3 months of treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Development of serious adverse effects leading to withdrawal of the drug
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Evidence of portal hypertension (esophagogastric varices or portal hypertensive gastropathy identified on esophagogastroduodenoscopy, and/or varices seen on computerized tomography scan or ultrasound, and/or splenomegaly with no other explanation, and/or ascites with no other explanation) Intrapulmonary vascular dilatations (IPVDs) diagnosed on contrast echocardiogram (CE) AaDO2 > 15 mm Hg on standing room air arterial blood gas (ABG) Ability and willingness to give informed consent Exclusion Criteria: Age < 18 or > 64 Intrinsic significant cardiopulmonary disease Inability to perform pulmonary function tests Moderate to severe Pulmonary hypertension Advanced hepatic encephalopathy Inadequate echocardiographic window to allow for accurate transthoracic contrast echocardiography Antibiotic use within the last one month Listed for liver transplant in next 4 weeks Current use of exogenous nitrates Active bacterial infections Known malignancy Known intolerance to Pentoxifylline or rifaximin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Naveen Kumar, MD
Phone
011-46300000
Email
naveenilbsdelhi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Ankit Bhardwaj
Phone
011-46300000
Ext
1032
Email
bhardwaj.ankit3@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Naveen Kumar, MD
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Naveen, MD
Phone
011-46300000
Email
naveenilbsdelhi@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr Ankit Bhardwaj
Phone
011-46300000
Ext
1032
Email
bhardwaj.ankit3@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Pentoxifylline and Rifaximin Combination in Pentoxifylline Refractory Clinical and Subclinical Hepatopulmonary Syndrome

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