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

Alcoholic Hepatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796469
• Other study ID #: MA_2016-01
• Status: Completed
• Phase: N/A
• First received: May 31, 2016
• Last updated: June 6, 2016
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1974
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Alcoholic Liver Disease
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

Drug:
• Pentoxifylline

• Corticosteroid

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		at 28 days, after the first administration of treatment	No
Secondary	Lille Model Score	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	No
Secondary	Biological measure : Bilirubin	evaluate of bilirubin during treatment period	at day 7, at day 28	No