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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00638144
First Posted: March 18, 2008
Last Update Posted: September 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
March 3, 2008
March 18, 2008
September 30, 2015
February 2008
December 2015   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00638144 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Prevention of Graft Reinfection After Liver Transplantation With Anti HCV Monoclonal Antibodies Identified in Chronically Infected Patients or in Patients With Resolved Hepatitis C
Prevention of Graft Reinfection After Liver Transplantation for HCV Related End-stage Liver Disease . Study of Humoral Anti-HCV Response
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
blood
Probability Sample
patients with resolved infection chronically infected patients
Hepatitis C
Not Provided
  • 1
    patients with resolved infection
  • 2
    chronically infected patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
300
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00638144
4109
No
Not Provided
Not Provided
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Principal Investigator: Michel DOFFOEL, MD CHRU Strasbourg
Principal Investigator: Albert FARADJI, MD CHRU Strasbourg
Principal Investigator: Philippe WOLF, MD CHRU Strasbourg
University Hospital, Strasbourg, France
September 2015