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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

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ClinicalTrials.gov Identifier: NCT00638144
Recruitment Status : Unknown
Verified September 2015 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : March 18, 2008
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date March 3, 2008
First Posted Date March 18, 2008
Last Update Posted Date September 30, 2015
Study Start Date February 2008
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood
Sampling Method Probability Sample
Study Population patients with resolved infection chronically infected patients
Condition Hepatitis C
Intervention Not Provided
Study Groups/Cohorts
  • 1
    patients with resolved infection
  • 2
    chronically infected patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March¬†10,¬†2008)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2015
Estimated Primary Completion Date December 2015   (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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00638144
Other Study ID Numbers 4109
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor University Hospital, Strasbourg, France
Collaborators Not Provided
Investigators
Principal Investigator: Michel DOFFOEL, MD CHRU Strasbourg
Principal Investigator: Albert FARADJI, MD CHRU Strasbourg
Principal Investigator: Philippe WOLF, MD CHRU Strasbourg
PRS Account University Hospital, Strasbourg, France
Verification Date September 2015