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

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT02796469

Collaborator

(none)

1,974

Enrollment

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholic Hepatitis Alcoholic Liver Disease	Drug: Pentoxifylline Drug: Corticosteroid Drug: Placebo

Study Design

Study Type:

Observational

Actual Enrollment :

1974 participants

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 Start Date :

May 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Pentoxifylline + Corticosteroid Association of treatment by pentoxifylline and corticosterone during 28 days	Drug: Pentoxifylline Drug: Corticosteroid
Corticosteroid treatment by corticosteroid during 28 days	Drug: Corticosteroid Drug: Placebo
Pentoxifylline treatment by pentoxifylline during 28 days	Drug: Pentoxifylline Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

Overall survival [at 28 days, after the first administration of treatment]

Secondary Outcome Measures

Lille Model Score [at day 7, after the first administration of treatment]
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 [at day 7, at day 28]
evaluate of bilirubin during treatment period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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