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Completed

NCT Number: NCT02796469

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

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.

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Key information

Conditions

Alcoholic Hepatitis Alcohol-Induced Disorders Alcohol-Related Disorders Alcoholic Liver Disease Chemically-Induced Disorders Digestive System Diseases Hepatitis Hepatitis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Pentoxifylline

Drug

Corticosteroid

Drug

Placebo

Drug

Primary outcomes

  1. Overall survival

    Time frame: at 28 days, after the first administration of treatment

Secondary outcomes

  1. Lille Model Score

    Time frame: 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.

  2. Biological measure : Bilirubin

    Time frame: at day 7, at day 28

    evaluate of bilirubin during treatment period

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Statistical Analysis Plan for an Individual Patient Data Meta-analysis of Ten Clinical Trials Comparing Drug Therapy in Patients With Severe Alcoholic Hepatitis

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 10, 2016
Registry last updated
Jun 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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