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Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

This study has been terminated.
(lack of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205049
First Posted: September 20, 2005
Last Update Posted: May 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of Pentoxifylline-Therapy for Acute Alcoholic Hepatitis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Survival at 28 Days [ Time Frame: 28 days ]

Enrollment: 4
Study Start Date: March 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: pentoxifylline
daily dosing
Other Name: no other names

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205049


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, Madison
ClinicalTrials.gov Identifier: NCT00205049     History of Changes
Other Study ID Numbers: M-2004-0388
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: August 4, 2011
Results First Posted: May 13, 2014
Last Update Posted: May 13, 2014
Last Verified: April 2014

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants