Clinical Trials Directory

Trials / Completed

CompletedNCT01756794

Validation of the Procedure of Early Liver Transplantation in Alcoholic Hepatitis Resisting to Medical Treatment

Validation of an Accelerated Procedure of Selection in Early Liver Transplantation for Severe Alcoholic Hepatitis Not Responding to Medical Treatment QuickTransHAA.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
284 (actual)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to validate a strategy of identification of patients for early liver transplantation in severe alcoholic hepatitis. In this setting, short-term survival is very low (approx. 25% at 6 months) and a pilot study has suggested (mathurin et al. N Engl J Med 2011) that liver transplantation may be an option in very carefully selected patients who did not respond to medical treatment. This selection process deserves to be confirmed in a population of greater size. We hypothesized that patients selected with this process would have a same alcohol relapse rate after liver transplantation than patients transplanted for alcoholic cirrhosis and selected using a 6-month sobriety period

Detailed description

Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.

Conditions

Interventions

TypeNameDescription
PROCEDURELiver transplantation

Timeline

Start date
2012-12-05
Primary completion
2018-06-07
Completion
2019-12-05
First posted
2012-12-27
Last updated
2025-12-22

Locations

32 sites across 2 countries: Belgium, France

Source: ClinicalTrials.gov record NCT01756794. Inclusion in this directory is not an endorsement.