Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-05 @ 6:28 PM
Study NCT ID:
NCT02796469
Status:
COMPLETED
Last Update Posted:
2016-06-10
First Post:
2016-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meta-Analysis of Drug Therapy in Patients With Severe Alcoholic Hepatitis
Sponsor:
University Hospital, Lille
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: