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

This study is currently recruiting participants.
Verified December 2012 by Institute of Liver and Biliary Sciences, India
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01676597
First received: August 29, 2012
Last updated: December 16, 2013
Last verified: December 2012
  Purpose
  • 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 Intervention
Hepatopulmonary Syndrome
Drug: pentoxifylline and rifaximin
Drug: Pentoxifylline and placebo

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

Resource links provided by NLM:


Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • Complete response after 3 months of treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Development of serious adverse effects leading to withdrawal of the drug [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676597

Contacts
Contact: Dr Naveen Kumar, MD 011-46300000 naveenilbsdelhi@gmail.com
Contact: Dr Ankit Bhardwaj 011-46300000 ext 1032 bhardwaj.ankit3@gmail.com

Locations
India
Institute of Liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Dr Naveen , MD    011-46300000    naveenilbsdelhi@gmail.com   
Contact: Dr Ankit Bhardwaj    011-46300000 ext 1032    bhardwaj.ankit3@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Principal Investigator: Dr Naveen Kumar, MD Institute of Liver and Biliary Sciences
  More Information

No publications provided

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01676597     History of Changes
Other Study ID Numbers: ILBS-HPS-01
Study First Received: August 29, 2012
Last Updated: December 16, 2013
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Hepatopulmonary Syndrome
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Pentoxifylline
Rifaximin
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Free Radical Scavengers
Antioxidants
Anti-Infective Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 23, 2014