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Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

Primary Purpose

Hepatitis, Alcoholic

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
pentoxifylline
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis, Alcoholic focused on measuring acute alcoholic hepatitis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Pentoxifylline/Placebo

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Survival at 28 Days

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    April 10, 2014
    Sponsor
    University of Wisconsin, Madison
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00205049
    Brief Title
    Pentoxifylline for Acute Alcoholic Hepatitis (AAH)
    Official Title
    A Pilot Study of Pentoxifylline-Therapy for Acute Alcoholic Hepatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Terminated
    Why Stopped
    lack of funding
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    November 2006 (Actual)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Wisconsin, Madison

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis, Alcoholic
    Keywords
    acute alcoholic hepatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    N/A
    Enrollment
    4 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pentoxifylline/Placebo
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    pentoxifylline
    Other Intervention Name(s)
    no other names
    Intervention Description
    daily dosing
    Primary Outcome Measure Information:
    Title
    Survival at 28 Days
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael R Lucey, MD
    Organizational Affiliation
    University of Wisconsin, Madison
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

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