Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

Hepatitis, Alcoholic Clinical Trial

Official title:

A Pilot Study of Pentoxifylline-Therapy for Acute Alcoholic Hepatitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00205049
• Other study ID #: M-2004-0388
• Status: Terminated
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: April 10, 2014
• Start date: March 2005
• Est. completion date: November 2006

Study information

• Verified date: April 2014
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic

Intervention

Drug:
• pentoxifylline
daily dosing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at 28 Days		28 days	No