Prevention of Graft Reinfection After Liver Transplantation With Anti HCV Monoclonal Antibodies Identified in Chronically Infected Patients or in Patients With Resolved Hepatitis C

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by University Hospital, Strasbourg, France
Information provided by (Responsible Party):
University Hospital, Strasbourg, France Identifier:
First received: March 3, 2008
Last updated: September 29, 2015
Last verified: September 2015

End stage HCV-related cirrhosis has become a major indication for liver transplantation (LT). Unfortunately, recurrence of HCV infection on the liver graft occurs in almost all patients following transplantation and causes a persistent infection that leads to chronic hepatitis and cirrhosis in a significant proportion of patients. To date there is no effective way to prevent HCV reinfection of the liver graft in the early phase after transplantation. . Early passive immunotherapy with neutralizing antibodies against HCV should be considered for preventing reinfection of liver transplanted patients associated with HCV. This approach is well established in the case of patients undergoing liver transplantation for chronic hepatitis B virus infection. Our purpose is to produce neutralizing monoclonal antibodies to prevent reinfection of the liver graft.

Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevention of Graft Reinfection After Liver Transplantation for HCV Related End-stage Liver Disease . Study of Humoral Anti-HCV Response

Resource links provided by NLM:

Further study details as provided by University Hospital, Strasbourg, France:

Biospecimen Retention:   Samples Without DNA


Estimated Enrollment: 300
Study Start Date: February 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
patients with resolved infection
chronically infected patients


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with resolved infection chronically infected patients


Inclusion Criteria:

  • Health insurance
  • Resolved HCV infection ( HCV RNA negative since more then 6 months ) -HCV chronically infected ( RNA positive )
  • Anti- HCV antibodies positive
  • Volunteers and informed patients

Exclusion Criteria:

  • Immunosuppression
  • HBV or HIV infection
  • Pregnancy
  • Breast feeding
  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 identifier: NCT00638144

Contact: BAUMERT Thomas, MD 00 333 90 24 36 99
Contact: Françoise STOLL-KELLER, MD 00 333 90 24 37 16

Service d'Hématologie et Oncologie - Hôpital de Hautepierre Recruiting
Strasbourg, France
Contact: Albert FARADJI, MD    00333.88.12.76 90   
Principal Investigator: Albert FARADJI, MD         
Service d'Hépato-Gastro-Entérologie - Hôpital Civil Recruiting
Strasbourg, France, 67000
Contact: Michel DOFFOEL, MD    00 333 88 11 62 49   
Principal Investigator: Michel DOFFOEL, MD         
Sub-Investigator: Ahmed ANANNA, MD         
Sub-Investigator: François HABERSETZER, MD         
Service de Chirurgie Générale et Transplantation Multiorganes - Hôpital de Hautepierre Not yet recruiting
Strasbourg, France
Contact: Philippe WOLF, MD    00333 88 12 72 78   
Principal Investigator: Philippe WOLF, MD         
Sub-Investigator: Bernard ELLERO, MD         
Sub-Investigator: Marie-Lorraine WOEHL-JAEGLE, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Michel DOFFOEL, MD CHRU Strasbourg
Principal Investigator: Albert FARADJI, MD CHRU Strasbourg
Principal Investigator: Philippe WOLF, MD CHRU Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT00638144     History of Changes
Other Study ID Numbers: 4109
Study First Received: March 3, 2008
Last Updated: September 29, 2015
Health Authority: France :Ministère de la recherche

Keywords provided by University Hospital, Strasbourg, France:
Hepatitis C
liver transplantation
antibodies mediated neutralization
monoclonal antibodies

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs processed this record on October 09, 2015