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

June 6, 2016 updated by: University Hospital, Lille

Statistical Analysis Plan for an Individual Patient Data Meta-analysis of Ten Clinical Trials Comparing 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1974

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe alcoholic hepatitis assessed by Discriminant Function (DF) ≥32.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: at 28 days, after the first administration of treatment
at 28 days, after the first administration of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at day 7, after the first administration of treatment
Biological measure : Bilirubin
Time Frame: at day 7, at day 28
evaluate of bilirubin during treatment period
at day 7, at day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Philippe Mathurin, MD, PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Estimate)

June 10, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA_2016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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