Skip to main content
OpenTrials
Completed

NCT Number: NCT01756794

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcoholic Hepatitis Alcohol-Induced Disorders Alcohol-Related Disorders Alcoholic Cirrhosis Chemically-Induced Disorders Digestive System Diseases Fibrosis Hepatitis Hepatitis, Alcoholic Liver Cirrhosis Liver Cirrhosis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZA, Antwerp, Edegem, Belgium

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liver Transplantation

Procedure

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Validation of the survival benefit of transplanted patients as compared to non-transplanted patients with severe alcoholic hepatitis

    Time frame: 2 years

    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. Reproducibility of an algorithm of selection for candidates to liver transplantation

    Time frame: 2 years

    Second secondary aim is to evaluate the reproducibility of the algorithm for selection of candidates for liver transplantation in three centers

  3. Incidence of alcohol relapse

    Time frame: 2 years

    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

  4. Pattern of alcohol relapse in the two groups of transplanted patients

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: QuickTrans

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Dec 27, 2012
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.