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Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

A Pilot Study of Pentoxifylline-Therapy for Acute Alcoholic Hepatitis

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00205049
Enrollment
4
Registered
2005-09-20
Start date
2005-03-31
Completion date
2006-11-30
Last updated
2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis, Alcoholic

Keywords

acute alcoholic hepatitis

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.

Interventions

DRUGpentoxifylline

daily dosing

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Survival at 28 Days28 days

Participant flow

Participants by arm

ArmCount
Pentoxifylline
All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
0
Placebo
All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
0
Total0

Baseline characteristics

Characteristic—
Age, Categorical
<=18 years
— Participants
Age, Categorical
>=65 years
— Participants
Age, Categorical
Between 18 and 65 years
— Participants
Sex/Gender, Customized
Female
— 0
Sex/Gender, Customized
Male
— 0

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Survival at 28 Days

Time frame: 28 days

Population: Study was terminated before any data was gathered/analyzed.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026