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Trial record 1 of 62 for:    "Hepatitis, Alcoholic"
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Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

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ClinicalTrials.gov Identifier: NCT00205049
Recruitment Status : Terminated (lack of funding)
First Posted : September 20, 2005
Results First Posted : May 13, 2014
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis, Alcoholic Drug: pentoxifylline Phase 1

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of Pentoxifylline-Therapy for Acute Alcoholic Hepatitis
Study Start Date : March 2005
Primary Completion Date : November 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: September 20, 2005    Key Record Dates
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, Alcoholic
Hepatitis
Hepatitis A
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