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

Not Applicable

• Conditions: Hepatopulmonary Syndrome
• Interventions: Drug: pentoxifylline and rifaximin; Drug: Pentoxifylline and placebo

• Registration Number: NCT01676597
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-31
• Study Start: 2012-09
• Status Verified: 2012-12
• Last Update Submitted: 2013-12-16
• Last Update Posted: 2013-12-17
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pentoxifylline and placebo	pentoxifylline and rifaximin	Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks
rifaximin and pentoxifylline	Pentoxifylline and placebo	Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Complete response after 3 months of treatment	3 months

Secondary Outcome Measures

Name	Time	Method
Development of serious adverse effects leading to withdrawal of the drug	3 months

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India