The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH...
Date First Received: September 13, 2005
Last Updated: September 22, 2008
Verified by: University of Wisconsin, Madison, September 2008
Clinical Trial Phase: Phase 3 | Start Date: March 2005
Overall Status: Completed
Brief Summary
Official Title: “A Pilot Study of Pentoxifylline-Therapy for Acute Alcoholic Hepatitis”
Condition Keyword(s):
Intervention(s):
The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Study Primary Completion Date: July 2008
Intervention(s) in this Clinical Trial
- Drug: pentoxifylline
Outcome Measures for this Clinical Trial
Primary Measures
- Survival at 90 days
Secondary Measures
- Survival at 28 days; the effect of pentoxifylline on circulating tumor necrosis factor (TNF), oxidative stress and renal function
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Inpatient with acute alcoholic hepatitis
- Model for End-Stage Liver Disease (MELD) of 15 or greater
- Recent alcohol abuse
Exclusion Criteria:
- Recent infection
- Other life threatening disease
- Severe coagulopathy
- Another non-alcoholic cause of liver disease
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Wisconsin, Madison
Overall Clinical Trial Officials and Contacts
Michael R Lucey, MD Principal Investigator University of Wisconsin, Madison
Additional Information
Information obtained from ClinicalTrials.gov on October 06, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00205049
Study ID Number: M-2004-0388
ClinicalTrials.gov Identifier: NCT00205049
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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