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

Hepatopulmonary Syndrome Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01676597
• Other study ID #: ILBS-HPS-01
• Status: Recruiting
• Phase: N/A
• First received: August 29, 2012
• Last updated: December 16, 2013
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: December 2012
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Naveen Kumar, MD
• Phone: 011-46300000
• Email: naveenilbsdelhi[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatopulmonary Syndrome

Intervention

Drug:
• pentoxifylline and rifaximin
Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks
• Pentoxifylline and placebo
Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response after 3 months of treatment		3 months	No
Secondary	Development of serious adverse effects leading to withdrawal of the drug		3 months	Yes