Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

Phase 1

Terminated

• Conditions: Hepatitis, Alcoholic
• Interventions: Drug: pentoxifylline

• Registration Number: NCT00205049
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Results First Submitted: 2011-08-04
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-10
• Last Update Submitted: 2014-04-10
• Results First Posted: 2014-05-13
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pentoxifylline/Placebo	pentoxifylline	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.

Primary Outcome Measures

Name	Time	Method
Survival at 28 Days	28 days