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

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Unknown status

CT.gov ID

NCT01676597

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatopulmonary Syndrome	Drug: pentoxifylline and rifaximin Drug: Pentoxifylline and placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Sep 1, 2012

Anticipated Primary Completion Date :

Sep 1, 2014

Anticipated Study Completion Date :

Sep 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Complete response after 3 months of treatment [3 months]

Secondary Outcome Measures

Development of serious adverse effects leading to withdrawal of the drug [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver and Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute of Liver and Biliary Sciences, India

ClinicalTrials.gov Identifier:

NCT01676597

Other Study ID Numbers:

ILBS-HPS-01

First Posted:

Aug 31, 2012

Last Update Posted:

Dec 17, 2013

Last Verified:

Dec 1, 2012

Additional relevant MeSH terms:

Hepatopulmonary Syndrome

Syndrome

Rifaximin

Pentoxifylline

Study Results

No Results Posted as of Dec 17, 2013