Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

NCT ID: NCT00205049

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2006-11-30

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.

Conditions

Hepatitis, Alcoholic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

pentoxifylline

Intervention Type: DRUG

daily dosing

Interventions

pentoxifylline

daily dosing

Intervention Type: DRUG

Other Intervention Names

no other names

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael R Lucey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Other Identifiers

M-2004-0388

Identifier Type: -

Identifier Source: org_study_id