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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 3, 2008

Last Updated Date

March 10, 2008

Start Date ^†

February 2008

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00638144 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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

Study Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Condition ^†

Hepatitis C

Intervention ^†

Study Arms / Comparison Groups

patients with resolved infection
chronically infected patients

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

300

Estimated Completion Date

September 2023

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: BAUMERT Thomas, MD	00 333 90 24 36 99	thomas.baumert@ viro-ulp.u-strasbg.fr
Contact: Françoise STOLL-KELLER, MD	00 333 90 24 37 16	francoise.stoll@viro-ulp.u-strasbg.fr

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00638144

Responsible Party

Emmanuel Lavoué Directeur adjoint de la recherche clinique et de l'innovation, CHU Strasbourg

Secondary IDs ^††

Study Sponsor ^†

University Hospital, Strasbourg, France

Collaborators ^††

Investigators ^†

Principal Investigator:	Michel DOFFOEL, MD	CHRU Strasbourg
Principal Investigator:	Albert FARADJI, MD	CHRU Strasbourg
Principal Investigator:	Philippe WOLF, MD	CHRU Strasbourg

Information Provided By

University Hospital, Strasbourg, France

Verification Date

March 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.