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

University Hospital, Lille

Status

Completed

Conditions

Alcoholic Liver Disease

Alcoholic Hepatitis

Treatments

Drug: Placebo

Drug: Pentoxifylline

Drug: Corticosteroid

Study type

Observational

Funder types

Other

Identifiers

NCT02796469

MA_2016-01

Details and patient eligibility

About

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.

Enrollment

1,974 patients

Sex

All

Ages

18+ years old

Volunteers

No 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