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

Alcoholic Hepatitis Clinical Trial

— QuickTrans  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756794
• Other study ID #: 2010-26
• Secondary ID: 2012-A00088-35
• Status: Completed
• Phase: N/A
• Start date: December 5, 2012
• Est. completion date: December 5, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: December 5, 2019
• Est. primary completion date: June 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Group A):

• Age > 18 years

• Maddrey score > 32

• Liver biopsy confirming the diagnosis of alcoholic hepatitis

• Non-response to medical treatment: Lille score = 0.45 at day 7, or early worsening of liver function (MELD score > 25) despite a low Lille score (< 0.45)

• Hospitalization stay < 1 month

• Algorithm score = 220/250.

Inclusion Criteria (Group B):

• Age >18 years

• Diagnosis of alcoholic cirrhosis

• Alcoholic withdrawal of 6 months minimum before inscription on the transplant list

• MELD score = 15 for patients with hepatocellular carcinoma responding to Milan criteria (1 node < 5 cm or 3 nodes < 3 cm)

• MELD score = 20 preferably for patients not displaying hepatocellular carcinoma and that did not obtain an "expert" component

• No recommendation of MELD score for patients having obtained an "expert" component

Non-inclusion Criteria (Group A and B):

• Bacterial or viral infection uncontrolled by medical treatment

• Fungal or aspergillosis uncontrolled infection

• Hepatocellular carcinoma or invasive cancer

• Positive test for HBsAg, Positive test for HIV,Positive PCR for HCV

• Portal thrombosis

• Pregnancy or breast-feeding woman

Related Conditions & MeSH terms

• Alcoholic Cirrhosis
• Alcoholic Hepatitis
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic
• Liver Cirrhosis, Alcoholic

Intervention

Procedure:
• Liver transplantation

Locations

Country	Name	City	State
Belgium	UZA	Anvers	Edegem
Belgium	ULB, Erasme	Bruxelles
Belgium	Hospital Sart Tilman	Liege
France	Univesity hospital	Amiens
France	University hospital	Angers
France	University hospital	Besançon
France	Hôpital Jean Verdier (AH-HP)	Bondy
France	University hospital	Brest
France	University hospital	Caen
France	Univesity hospital	Chambray les tours
France	Hospital Antoine Béclère (Assistance Publique des Hôpiaux de Paris)	Clamart
France	Hôpital Beaujon (AH-HP)	Clichy
France	Hôpital Henri Mondor (AP-HP)	Créteil
France	University hospital	Dijon
France	University hospital	Grenoble
France	University hospital	Lille
France	University hospital	Lyon
France	University Hospital	Montpellier
France	University hospital	Nancy
France	University hospital	Nantes
France	University hospital	Nice
France	Hôpital Cochin (AH-HP)	Paris
France	Hôpital de la Pitié-Salpétrière (AP-HP)	Paris
France	Hôpital Saint Antoine (AP-HP)	Paris
France	University Hospital	Pessac
France	University hospital	Poitiers
France	University hospital	Reims
France	University hospital	Rennes
France	University Hospital	Strasbourg
France	University hospital	Toulouse
France	Hôpital Paul Brousse (AH-HP)	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.	Aim is to demonstrate that alcohol relapse within the 2-year follow-up period in patients selected for early liver transplantation for severe alcoholic hepatitis is not inferior to that of patients transplanted for alcoholic cirrhosis using the 6-month sobriety period.	2 years
Secondary	Validation of the survival benefit of transplanted patients as compared to non-transplanted patients with severe alcoholic hepatitis	First secondary aim is to confirm the survival benefit of patients transplanted for severe alcoholic hepatitis as compared to patients suffering for severe alcoholic hepatitis not responding to medical treatment and not selected for early liver transplantation	2 years
Secondary	Reproducibility of an algorithm of selection for candidates to liver transplantation	Second secondary aim is to evaluate the reproducibility of the algorithm for selection of candidates for liver transplantation in three centers	2 years
Secondary	Incidence of alcohol relapse	Third secondary endpoint is to compare the incidence of alcohol relapse in patients selected for early transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis using the 6-month sobriety period rule	2 years
Secondary	Pattern of alcohol relapse in the two groups of transplanted patients	Fourth secondary endpoint is to assess the pattern of alcohol relapse in the group of patients transplanted for severe alcoholic hepatitis to the group of patients transplanted for alcoholic cirrhosis using the 6-month sobriety rule.	2 years