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
About this trial
This is an observational trial for Alcoholic Hepatitis
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:
-
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
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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