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
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.
n/a
N/A
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04066179 -
Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients.
|
N/A | |
Completed |
NCT03732586 -
Effect of Omega 5 Fatty Acid as an Adyuvant Treatment to Prednisone in Patients With Severe Alcoholic Hepatitis
|
N/A | |
Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
Completed |
NCT00962442 -
N-Acetylcysteine in Severe Acute Alcoholic Hepatitis
|
Phase 3 | |
Not yet recruiting |
NCT06307522 -
MRG-001 in Patients With Alcoholic Hepatitis
|
Phase 2 | |
Recruiting |
NCT05018481 -
HA35 Moderate Alcoholic Hepatitis (AH) Study
|
Early Phase 1 | |
Completed |
NCT04544020 -
Changes in gUt micRobiota After Enteral Feeding (in Alcoholic Hepatitis)
|
||
Recruiting |
NCT04088370 -
Peripheral Blood Mononuclear Cells Response In Healthy Controls, Heavy Drinkers, and Patients With Alcoholic Hepatitis
|
||
Completed |
NCT04235855 -
EUS Guided Liver Biopsy - Will it Give Better Yield, More Tissue With Less Complication?
|
N/A | |
Active, not recruiting |
NCT02344680 -
Liver Fibrosis in Zambian HIV-HBV Co-infected Patients
|
||
Completed |
NCT00851981 -
Randomized, Controlled Trial of S-adenosylmethionine in Alcoholic Liver Disease
|
Phase 2 | |
Completed |
NCT04084522 -
Effect of Saturated Fat (Desi Ghee) on Gut-Liver Axis in Alcoholic Hepatitis
|
N/A | |
Completed |
NCT05840640 -
Granulocyte Colony Stimulating Factor Four Week Plus N-Acetyl Cysteine in Severe Alcoholic Hepatitis
|
Phase 4 | |
Recruiting |
NCT03069300 -
N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis
|
Phase 3 | |
Terminated |
NCT02039219 -
Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)
|
Phase 2 | |
Completed |
NCT02019056 -
Efficacy and Safety of MG in the Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis
|
Phase 2 | |
Completed |
NCT01245257 -
Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis
|
N/A | |
Completed |
NCT00388323 -
Adipose Tissue Involvement in Alcohol-induced Liver Inflammation in Human
|
N/A | |
Recruiting |
NCT03845205 -
Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for SAH
|
N/A | |
Recruiting |
NCT03703674 -
GCSF in Alcoholic Hepatitis
|
Phase 4 |