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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
First received
Last updated
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
Health authority
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

Study Design


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
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