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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Liver 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.