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

March 31, 2020 updated by: University Hospital, Lille

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1070
        • ULB, Erasme
      • Gent, Belgium
      • Liege, Belgium
        • Hospital Sart Tilman
    • Edegem
      • Anvers, Edegem, Belgium, B-2650
        • UZA
  • France
      • Amiens, France, 80054
        • Univesity Hospital
      • Angers, France, 49933
        • University Hospital
      • Besançon, France, 25030
        • University Hospital
      • Bondy, France, 93143
        • Hôpital Jean Verdier (AH-HP)
      • Brest, France, 29609
        • University Hospital
      • Caen, France, 14000
        • University Hospital
      • Chambray les tours, France, 37170
        • Univesity Hospital
      • Clamart, France, 92141
        • Hospital Antoine Béclère (Assistance Publique des Hôpiaux de Paris)
      • Clichy, France, 92118
        • Hôpital Beaujon (AH-HP)
      • Créteil, France, 94000
        • Hôpital Henri Mondor (AP-HP)
      • Dijon, France, 21079
        • University Hospital
      • Grenoble, France, 38043
        • University Hospital
      • Lille, France, 59037
        • University Hospital
      • Lyon, France, 69437
        • University Hospital
      • Montpellier, France, 34295
        • University Hospital
      • Nancy, France, 54500
        • University Hospital
      • Nantes, France, 44035
        • University Hospital
      • Nice, France, 06202
        • University Hospital
      • Paris, France, 75012
        • Hôpital Saint Antoine (AP-HP)
      • Paris, France, 75013
        • Hôpital de la Pitié-Salpétrière (AP-HP)
      • Paris, France, 75014
        • Hôpital Cochin (AH-HP)
      • Pessac, France, 33604
        • University Hospital
      • Poitiers, France, 86021
        • University Hospital
      • Reims, France, 51092
        • University Hospital
      • Rennes, France, 35033
        • University Hospital
      • Strasbourg, France, 67100
        • University Hospital
      • Toulouse, France, 31059
        • University Hospital
      • Villejuif, France, 94000
        • Hôpital Paul Brousse (AH-HP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Transplantation of alcoholic hepatitis
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
Procedure: Liver transplantation
Other: Transplantation for alcoholic cirrhosis
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.
Procedure: Liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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
2 years
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
2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Ministry of Health, France

Investigators

  • Study Chair: Philippe Mathurin, MD,PhD, University hospital of Lille,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2012

Primary Completion (Actual)

June 7, 2018

Study Completion (Actual)

December 5, 2019

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 27, 2012

Study Record Updates

Last Update Posted (Actual)

April 2, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-26
  • 2012-A00088-35 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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