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

Statistical Analysis Plan for an Individual Patient Data Meta-analysis of Ten Clinical Trials Comparing Drug Therapy in Patients With Severe Alcoholic Hepatitis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02796469

Enrollment

1974

Registered

2016-06-10

Start date

2015-05-31

Completion date

2016-05-31

Last updated

2016-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Hepatitis, Alcoholic Liver Disease

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.

Interventions

DRUGPentoxifylline

DRUGCorticosteroid

DRUGPlacebo

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Overall survival	at 28 days, after the first administration of treatment

Secondary

Measure	Time frame	Description
Lille Model Score	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.
Biological measure : Bilirubin	at day 7, at day 28	evaluate of bilirubin during treatment period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026