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

NCT02796469 | Completed

• 1 other identifier: MA_2016-01
• Study Type: observational
• Target: 1,974
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alcoholic Hepatitis; Alcoholic Liver Disease

Outcome Measures

Primary Outcomes (1)

• Overall survival

  at 28 days, after the first administration of treatment

Secondary Outcomes (2)

• Lille Model Score

  at day 7, after the first administration of treatment

• Biological measure : Bilirubin

  at day 7, at day 28

Study Arms (4)

Pentoxifylline + Corticosteroid

Association of treatment by pentoxifylline and corticosterone during 28 days

Drug: Pentoxifylline; Drug: Corticosteroid

Corticosteroid

treatment by corticosteroid during 28 days

Drug: Corticosteroid; Drug: Placebo

Pentoxifylline

treatment by pentoxifylline during 28 days

Drug: Pentoxifylline; Drug: Placebo

Placebo

Interventions

Pentoxifylline DRUG

Pentoxifylline; Pentoxifylline + Corticosteroid

Corticosteroid DRUG

Corticosteroid; Pentoxifylline + Corticosteroid

Placebo DRUG

Corticosteroid; Pentoxifylline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead

MeSH Terms

Conditions

Hepatitis, Alcoholic; Liver Diseases, Alcoholic

Interventions

Pentoxifylline; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Philippe Mathurin, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 10, 2016
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 10, 2016

Record last verified: 2016-06