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Clinical Trials/NCT00638144
NCT00638144UnknownNot Applicable

Prevention of Graft Reinfection After Liver Transplantation for HCV Related End-stage Liver Disease . Study of Humoral Anti-HCV Response

University Hospital, Strasbourg, France3 sites in 1 country300 target enrollmentStarted: February 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
300
Locations
3

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor
University Hospital, Strasbourg, France
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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