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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University Hospital, Lille
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01756794
First received: December 20, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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


Condition Intervention
Alcoholic Hepatitis
Alcoholic Cirrhosis
Procedure: Liver transplantation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Validation of an Accelerated Procedure of Selection in Early Liver Transplantation for Severe Alcoholic Hepatitis Not Responding to Medical Treatment QuickTransHAA.

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Validation of the survival benefit of transplanted patients as compared to non-transplanted patients with severe alcoholic hepatitis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    First secondary aim is to confirm the survival benefit of patients transplanted for svere alcoholic hepatitis as compared to patients suffering for severe alcoholic hepatitis not responding to medical treatment and not selected for early liver transplantation

  • Reproducibility of an algorithm of selection for candidates to liver transplantation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Second secondary aim is to evaluate the reproducibility of the algorithm for selection of candidates for liver transplantation in three centers

  • Incidence of alcohol relapse [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Third secondary endpoint is to compare the incidecne 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

  • Pattern of alcohol relapse in the two groups of transplanted patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Fourth secondary endopoint 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.


Estimated Enrollment: 263
Study Start Date: December 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years
  • Maddrey function > 32
  • Liver biopsy confirming the diagnosis of alcoholic hepatitis
  • Non-response to medical treatment assessed by a Lille model > 0.45 at day 7 or an early worsening of liver function (MELD score >25) despite a low Lille score (<0.45)
  • Hospitalization stay >1 month
  • Algorithm score ≥ 220/250.
  • Personne ne bénéficiant pas d'un régime de protection juridique (tutelle/curatelle)
  • Assuré social
  • Written informed consent

Exclusion Criteria:

  • Bacterial or viral uncontrolled by medical treatment
  • Fungal infection or invasive
  • Cancer or hepatocellular carcinoma
  • Positive testing for HBsAg
  • Positive testing for HIV
  • Positive PCR for HCV
  • Portal thrombosis
  • Pregnancy or breast-feeding
  • Impossibilité de recevoir une information éclairée chez les patients encéphalopathes et ne disposant pas d'une personne de confiance
  • Impossibilité de participer à la totalité de l'étude
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756794

Contacts
Contact: Mathurin Philippe, MD,PhD phillippe.mathurin@chru-lille.fr
Contact: Louvet Alexandre, MD alexandre.louvet@chru-lille.fr

Locations
Belgium
ULB, Erasme Not yet recruiting
Bruxelles, Belgium, 1070
Principal Investigator: Christophe Moreno, MD,PhD         
France
Univesity hospital Not yet recruiting
Amiens, France, 80054
Principal Investigator: N Guyen-Khac, MD, PhD         
University hospital Not yet recruiting
Angers, France, 49933
Principal Investigator: F Oberty, MD, PhD         
University hospital Not yet recruiting
Besançon, France, 25030
Principal Investigator: C Vanlemmens, MD,PhD         
Hôpital Jean Verdier (AH-HP) Not yet recruiting
Bondy, France, 93143
Principal Investigator: Nathalie Ganne, MD PhD         
University hospital Not yet recruiting
Brest, France, 29609
Principal Investigator: JB Nousbaum, MD,PhD         
University hospital Not yet recruiting
Caen, France, 14000
Principal Investigator: T Dao, MD, PhD         
Univesity hospital Not yet recruiting
Chambray les tours, France, 37170
Principal Investigator: E Salame, MD,PhD         
Hospital Antoine Béclère (Assistance Publique des Hôpiaux de Paris) Not yet recruiting
Clamart, France, 92141
Principal Investigator: Sylvie Naveau, MD PhD         
Hôpital Beaujon (AH-HP) Not yet recruiting
Clichy, France, 92118
Principal Investigator: François Durand, MD PhD         
Hôpital Henri Mondor (AP-HP) Active, not recruiting
Créteil, France, 94000
University hospital Not yet recruiting
Dijon, France, 21079
Principal Investigator: P Hillon, Md,PhD         
University hospital Not yet recruiting
Grenoble, France, 38043
Principal Investigator: V Leroy, Md,PhD         
University hospital Recruiting
Lille, France, 59037
Principal Investigator: Philippe Mathurin, MD PhD         
University hospital Not yet recruiting
Lyon, France, 69437
Principal Investigator: J Dumortier, MD,PhD         
University Hospital Not yet recruiting
Montpellier, France, 34295
Principal Investigator: GP Pageaux, Md,PhD         
University hospital Not yet recruiting
Nancy, France, 54500
Principal Investigator: JP Bronovicki, MD,PhD         
University hospital Not yet recruiting
Nantes, France, 44035
Principal Investigator: D gournay, MD,PhD         
University hospital Not yet recruiting
Nice, France, 06202
Principal Investigator: R Anty, MD,PhD         
Hôpital Saint Antoine (AP-HP) Active, not recruiting
Paris, France, 75012
Hôpital Cochin (AH-HP) Not yet recruiting
Paris, France, 75014
Principal Investigator: P Sogni, MD PhD         
Hôpital de la Pitié-Salpétrière (AP-HP) Active, not recruiting
Paris, France, 75013
University Hospital Not yet recruiting
Pessac, France, 33604
Principal Investigator: V De Lédinghen, MD, PhD         
University hospital Not yet recruiting
Poitiers, France, 86021
Principal Investigator: C Sylvain, MD, PhD         
University hospital Not yet recruiting
Reims, France, 51092
Principal Investigator: Brigitte Bernard-Chabert, MD,PhD         
University hospital Not yet recruiting
Rennes, France, 35033
Principal Investigator: Romain Moirand, MD,PhD         
University Hospital Not yet recruiting
Strasbourg, France, 67100
Principal Investigator: P Bachelier, MD,PhD         
University hospital Not yet recruiting
Toulouse, France, 31059
Principal Investigator: JM Perron, Md,PhD         
Hôpital Paul Brousse (AH-HP) Active, not recruiting
Villejuif, France, 94000
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
Study Chair: Philippe Mathurin, MD,PhD University hospital of Lille,
  More Information

No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01756794     History of Changes
Other Study ID Numbers: PROM 2010-26, 2012-A00088-35
Study First Received: December 20, 2012
Last Updated: December 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Lille:
Alcoholic hepatitis
Liver transplantation
Alcohol relapse
Alcoholic cirrhosis

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Hepatitis
Hepatitis A
Liver Cirrhosis, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Digestive System Diseases
Enterovirus Infections
Hepatitis, Viral, Human
Liver Cirrhosis
Liver Diseases
Liver Diseases, Alcoholic
Picornaviridae Infections
RNA Virus Infections
Substance-Related Disorders
Virus Diseases
Liver Extracts
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014