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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02796469
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Information provided by (Responsible Party):
University Hospital, Lille

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
Alcoholic Hepatitis Alcoholic Liver Disease Drug: Pentoxifylline Drug: Corticosteroid Drug: Placebo

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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 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Overall survival [ Time Frame: at 28 days, after the first administration of treatment ]

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe alcoholic hepatitis assessed by Discriminant Function (DF) ≥32.

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02796469

Sponsors and Collaborators
University Hospital, Lille
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Principal Investigator: Philippe Mathurin, MD, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille Identifier: NCT02796469    
Other Study ID Numbers: MA_2016-01
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hepatitis A
Liver Diseases
Hepatitis, Alcoholic
Liver Diseases, Alcoholic
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers