This trial is active, not recruiting.

Conditions alcoholic hepatitis, alcoholic cirrhosis
Treatment liver transplantation
Sponsor University Hospital, Lille
Collaborator Ministry of Health, France
Start date December 2012
End date January 2019
Trial size 263 participants
Trial identifier NCT01756794, 2010-26, 2012-A00088-35


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Patients of this arm will be selected for early liver transplantation for severe alcoholic hepatitis not responding to medical therapy. Selection process will be based on a specific algorithm and follow-up time will be 2 years
liver transplantation
Patients of this arm will be selected for liver transplantation for alcoholic cirrhosis using an abstinence period of 6 months. Outcome of these patients will be compared to that of patients transplanted for severe alcoholic hepatitis.
liver transplantation

Primary Outcomes

Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.
time frame: 2 years

Secondary Outcomes

Validation of the survival benefit of transplanted patients as compared to non-transplanted patients with severe alcoholic hepatitis
time frame: 2 years
Reproducibility of an algorithm of selection for candidates to liver transplantation
time frame: 2 years
Incidence of alcohol relapse
time frame: 2 years
Pattern of alcohol relapse in the two groups of transplanted patients
time frame: 2 years

Eligibility Criteria

All participants at least 18 years old.

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

Additional Information

Official title Validation of an Accelerated Procedure of Selection in Early Liver Transplantation for Severe Alcoholic Hepatitis Not Responding to Medical Treatment QuickTransHAA.
Description Non-inferiority of alcohol relapse in early liver transplantation for severe alcoholic hepatitis as compared to patients transplanted for alcoholic cirrhosis.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by University Hospital, Lille.