Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

University of Wisconsin (UW)

Status and phase: Terminated; Phase 1

Conditions: Hepatitis, Alcoholic

Treatments: Drug: pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT00205049

M-2004-0388

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

---

4 participants in 1 patient group

Pentoxifylline/Placebo

Experimental group

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.

Treatment:

Drug: pentoxifylline