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

University Hospital, Strasbourg, France

Status: Unknown

Conditions: Hepatitis C

Study type: Observational

Funder types: Other

Identifiers

NCT00638144

4109

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

1

Description:

patients with resolved infection

2

Description:

chronically infected patients