MedPath

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

Conditions
Hepatitis C
Registration Number
NCT00638144
Lead Sponsor
University Hospital, Strasbourg, France
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
300
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Service de Chirurgie Générale et Transplantation Multiorganes - Hôpital de Hautepierre

🇫🇷

Strasbourg, France

Service d'Hépato-Gastro-Entérologie - Hôpital Civil

🇫🇷

Strasbourg, France

Service d'Hématologie et Oncologie - Hôpital de Hautepierre

🇫🇷

Strasbourg, France

© Copyright 2025. All Rights Reserved by MedPath