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Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205049
First received: September 13, 2005
Last updated: September 22, 2008
Last verified: September 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Pilot Study of Pentoxifylline-Therapy for Acute Alcoholic Hepatitis

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

Keywords provided by University of Wisconsin, Madison:
acute alcoholic hepatitis

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pentoxifylline
 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

ClinicalTrials.gov processed this record on May 21, 2013