Efficacy of Pentoxifylline and Rifaximin Combination in Pentoxifylline Refractory Clinical and Subclinical Hepatopulmonary Syndrome
NCT ID: NCT01676597
Last Updated: 2013-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
80 participants
INTERVENTIONAL
2012-09-30
2014-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
rifaximin and pentoxifylline
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
pentoxifylline and placebo
Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks
pentoxifylline and rifaximin
Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* 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
18 Years
64 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dr Naveen Kumar, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Liver and Biliary Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Dr Naveen, MD
Role: primary
Dr Ankit Bhardwaj
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ILBS-HPS-01
Identifier Type: -
Identifier Source: org_study_id