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Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

This study has been terminated.
(lack of funding)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205049
First received: September 13, 2005
Last updated: April 10, 2014
Last verified: April 2014

September 13, 2005
April 10, 2014
March 2005
November 2006   (final data collection date for primary outcome measure)
Survival at 28 Days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Survival at 90 days
Complete list of historical versions of study NCT00205049 on ClinicalTrials.gov Archive Site
Not Provided
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.

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.

This study never moved forward due to funding issues.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatitis, Alcoholic
Drug: pentoxifylline
daily dosing
Other Name: no other names
Experimental: Pentoxifylline/Placebo
All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days (20-40 treated, 1-20 placebo) with monthly follow up for 90 days.
Intervention: Drug: pentoxifylline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
November 2006
November 2006   (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
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00205049
M-2004-0388
No
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Michael R Lucey, MD University of Wisconsin, Madison
University of Wisconsin, Madison
April 2014

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