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Meta-Analysis of Drug Therapy in Patients With Severe Alcoholic Hepatitis

Primary Purpose

Alcoholic Hepatitis, Alcoholic Liver Disease

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Pentoxifylline
Corticosteroid
Placebo
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Alcoholic Hepatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients included in 10 randomized controlled trials testing either corticosteroids alone, or pentoxifylline alone or their combination have been published.

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Arm Label

    Pentoxifylline + Corticosteroid

    Corticosteroid

    Pentoxifylline

    Placebo

    Arm Description

    Association of treatment by pentoxifylline and corticosterone during 28 days

    treatment by corticosteroid during 28 days

    treatment by pentoxifylline during 28 days

    Outcomes

    Primary Outcome Measures

    Overall survival

    Secondary Outcome Measures

    Lille Model Score
    Lille model evaluate to therapy and will be analyzed as dichotomous outcome (<0.45 vs. ≥0.45), ordinal outcome (≤0.16 vs. 0.16-0.56 vs. ≥ 0.56) and continuous outcome (after log-transformation) and will be restricted to patients with a dosage of bilirubin at day 7 after initiation of assignment treatment.
    Biological measure : Bilirubin
    evaluate of bilirubin during treatment period

    Full Information

    First Posted
    May 31, 2016
    Last Updated
    June 6, 2016
    Sponsor
    University Hospital, Lille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02796469
    Brief Title
    Meta-Analysis of Drug Therapy in Patients With Severe Alcoholic Hepatitis
    Official Title
    Statistical Analysis Plan for an Individual Patient Data Meta-analysis of Ten Clinical Trials Comparing Drug Therapy in Patients With Severe Alcoholic Hepatitis
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Lille

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In the specific setting of the evaluation of corticosteroids, pentoxifylline of their combination in severe alcoholic hepatitis, only meta-analysis combining individual data is able to provide detailed information from each individual with severe alcoholic hepatitis assessed by a DF ≥ 32. The need for such an approach is confirmed by the fact that in both univariate and multivariate analyses, truth survival is lower for conclusions from meta-analysis of the literature than for conclusions derived from non-meta-analyses. The present study is a meta-analysis of individual data from RCTs restricted to patients with a DF ≥ 32. The primary endpoint will be to compare 28-day survival of patients receiving either corticosteroids, or pentoxifylline or their combination to those of patients not receiving them adjusted on the independent prognostic factors at baseline. The secondary endpoints will be: a) assessment of response to the assigned treatment using the Lille model; b) analysis of 6-month survival according to allocated therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcoholic Hepatitis, Alcoholic Liver Disease

    7. Study Design

    Enrollment
    1974 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pentoxifylline + Corticosteroid
    Arm Description
    Association of treatment by pentoxifylline and corticosterone during 28 days
    Arm Title
    Corticosteroid
    Arm Description
    treatment by corticosteroid during 28 days
    Arm Title
    Pentoxifylline
    Arm Description
    treatment by pentoxifylline during 28 days
    Arm Title
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Pentoxifylline
    Intervention Type
    Drug
    Intervention Name(s)
    Corticosteroid
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Overall survival
    Time Frame
    at 28 days, after the first administration of treatment
    Secondary Outcome Measure Information:
    Title
    Lille Model Score
    Description
    Lille model evaluate to therapy and will be analyzed as dichotomous outcome (<0.45 vs. ≥0.45), ordinal outcome (≤0.16 vs. 0.16-0.56 vs. ≥ 0.56) and continuous outcome (after log-transformation) and will be restricted to patients with a dosage of bilirubin at day 7 after initiation of assignment treatment.
    Time Frame
    at day 7, after the first administration of treatment
    Title
    Biological measure : Bilirubin
    Description
    evaluate of bilirubin during treatment period
    Time Frame
    at day 7, at day 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients included in 10 randomized controlled trials testing either corticosteroids alone, or pentoxifylline alone or their combination have been published. Exclusion Criteria: -
    Study Population Description
    Patients with severe alcoholic hepatitis assessed by Discriminant Function (DF) ≥32.
    Sampling Method
    Non-Probability Sample
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Philippe Mathurin, MD, PhD
    Organizational Affiliation
    University Hospital, Lille
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Meta-Analysis of Drug Therapy in Patients With Severe Alcoholic Hepatitis

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