Validation of the Procedure of Early Liver Transplantation in Alcoholic Hepatitis Resisting to Medical Treatment (QuickTrans)
This study is currently recruiting participants.
Verified December 2012 by University Hospital, Lille
Sponsor:
University Hospital, Lille
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
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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:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
Drug Information available for:
Hepatitis A Vaccines
U.S. FDA Resources
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
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 Hepatitis A Hepatitis, Alcoholic Liver Cirrhosis Fibrosis Liver Cirrhosis, Alcoholic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Liver Diseases, Alcoholic Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013