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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01676597

Enrollment

Registered

2012-08-31

Start date

2012-09-30

Completion date

2014-09-30

Last updated

2013-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatopulmonary Syndrome

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.

Interventions

DRUGpentoxifylline and rifaximin

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

DRUGPentoxifylline and placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Complete response after 3 months of treatment	3 months

Secondary

Measure	Time frame
Development of serious adverse effects leading to withdrawal of the drug	3 months

Countries

India

Contacts

Primary ContactDr Naveen Kumar, MD

naveenilbsdelhi@gmail.com011-46300000

Backup ContactDr Ankit Bhardwaj

bhardwaj.ankit3@gmail.com011-46300000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026