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

NCT01676597 | Unknown

• 1 other identifier: ILBS-HPS-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatopulmonary Syndrome

Outcome Measures

Primary Outcomes (1)

• Complete response after 3 months of treatment

  3 months

Secondary Outcomes (1)

• Development of serious adverse effects leading to withdrawal of the drug

  3 months

Study Arms (2)

rifaximin and pentoxifylline

EXPERIMENTAL

Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks

Drug: Pentoxifylline and placebo

pentoxifylline and placebo

ACTIVE COMPARATOR

Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks

Drug: pentoxifylline and rifaximin

Interventions

pentoxifylline and rifaximin DRUG

Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks

pentoxifylline and placebo

Pentoxifylline and placebo DRUG

Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks

rifaximin and pentoxifylline

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Hepatopulmonary Syndrome

Interventions

Pentoxifylline; Rifaximin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Dr Naveen Kumar, MD

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Naveen Kumar, MD

CONTACT

011-46300000; naveenilbsdelhi@gmail.com

Dr Ankit Bhardwaj

CONTACT

011-46300000; bhardwaj.ankit3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: August 31, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 17, 2013

Record last verified: 2012-12

Locations

IN (1)