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

NCT02796469 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1974

Last updated 2016-06-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pentoxifylline

DRUG

Corticosteroid

DRUG

Placebo

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Philippe Mathurin, MD, PhD · University Hospital, Lille

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-05-31
Completion
2016-05-31

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02796469 on ClinicalTrials.gov