Pentoxifylline for Acute Alcoholic Hepatitis (AAH)
Primary Purpose
Hepatitis, Alcoholic
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
pentoxifylline
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis, Alcoholic focused on measuring acute alcoholic hepatitis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pentoxifylline/Placebo
Arm Description
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.
Outcomes
Primary Outcome Measures
Survival at 28 Days
Secondary Outcome Measures
Full Information
NCT ID
NCT00205049
First Posted
September 13, 2005
Last Updated
April 10, 2014
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00205049
Brief Title
Pentoxifylline for Acute Alcoholic Hepatitis (AAH)
Official Title
A Pilot Study of Pentoxifylline-Therapy for Acute Alcoholic Hepatitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
lack of funding
Study Start Date
March 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis, Alcoholic
Keywords
acute alcoholic hepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pentoxifylline/Placebo
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
pentoxifylline
Other Intervention Name(s)
no other names
Intervention Description
daily dosing
Primary Outcome Measure Information:
Title
Survival at 28 Days
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R Lucey, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Pentoxifylline for Acute Alcoholic Hepatitis (AAH)
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