Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

This study has been completed.

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00205049

Purpose

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.

Condition	Intervention	Phase
Hepatitis, Alcoholic	Drug: pentoxifylline	Phase III

MedlinePlus related topics: Hepatitis

Drug Information available for: Pentoxifylline Pentoxyl

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	A Pilot Study of Pentoxifylline-Therapy for Acute Alcoholic Hepatitis

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Survival at 90 days

Secondary Outcome Measures:

Survival at 28 days; the effect of pentoxifylline on circulating tumor necrosis factor (TNF), oxidative stress and renal function

Study Start Date:	March 2005
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205049

Locations

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 57392

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Michael R Lucey, MD

University of Wisconsin, Madison

More Information

Responsible Party:	University of Wisconsin ( Michael R. Lucey, MD )
Study ID Numbers:	M-2004-0388
Study First Received:	September 13, 2005
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00205049
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

acute alcoholic hepatitis

Study placed in the following topic categories:

Alcohol-Induced Disorders
Hepatitis
Liver Diseases, Alcoholic
Liver Diseases
Digestive System Diseases

Substance-Related Disorders
Hepatitis, Alcoholic
Disorders of Environmental Origin
Alcohol-Related Disorders
Pentoxifylline

Additional relevant MeSH terms:

Radiation-Protective Agents
Vasodilator Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Therapeutic Uses
Free Radical Scavengers
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009