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

NCT01676597 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-12-17

No results posted yet for this study

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.

Conditions

  • Hepatopulmonary Syndrome

Interventions

DRUG

pentoxifylline and rifaximin

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

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Principal Investigators

  • Dr Naveen Kumar, MD · Institute of Liver and Biliary Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01676597 on ClinicalTrials.gov