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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00638144
• Other study ID #: 4109
• Status: Recruiting
• Phase: N/A
• First received: March 3, 2008
• Last updated: September 29, 2015
• Start date: February 2008
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: University Hospital, Strasbourg, France
• Contact: BAUMERT Thomas, MD
• Phone: 00 333 90 24 36 99
• Email: thomas.baumert[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France :Ministère de la recherche
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
France	Service d'Hématologie et Oncologie - Hôpital de Hautepierre	Strasbourg
France	Service d'Hépato-Gastro-Entérologie - Hôpital Civil	Strasbourg
France	Service de Chirurgie Générale et Transplantation Multiorganes - Hôpital de Hautepierre	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France,