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

December 16, 2013 updated by: Institute of Liver and Biliary Sciences, India
  • 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rifaximin and pentoxifylline
Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks
Drug: Pentoxifylline and placebo
Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks
Active Comparator: pentoxifylline and placebo
Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks
Drug: pentoxifylline and rifaximin
Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete response after 3 months of treatment
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Development of serious adverse effects leading to withdrawal of the drug
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

  • Principal Investigator: Dr Naveen Kumar, MD, Institute of liver and Biliary Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

August 29, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (Estimate)

August 31, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 16, 2013

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-HPS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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