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

September 13, 2005
September 22, 2008
March 2005
July 2008   (final data collection date for primary outcome measure)
Survival at 90 days
Same as current
Complete list of historical versions of study NCT00205049 on ClinicalTrials.gov Archive Site
Survival at 28 days; the effect of pentoxifylline on circulating tumor necrosis factor (TNF), oxidative stress and renal function
Survival at 28 days; the effect of pentoxifylline on circulating TNF, oxidative stress and renal function
Not Provided
Not Provided
 
Pentoxifylline for Acute Alcoholic Hepatitis (AAH)
A Pilot Study of Pentoxifylline-Therapy for Acute Alcoholic Hepatitis

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hepatitis, Alcoholic
Drug: pentoxifylline
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205049
M-2004-0388
No
Michael R. Lucey, MD, University of Wisconsin
University of Wisconsin, Madison
Not Provided
Principal Investigator: Michael R Lucey, MD University of Wisconsin, Madison
University of Wisconsin, Madison
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP