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Sponsored by: |
University Hospital, Strasbourg, France |
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Information provided by: | University Hospital, Strasbourg, France |
ClinicalTrials.gov Identifier: | NCT00638144 |
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.
Condition |
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Hepatitis C |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Prevention of Graft Reinfection After Liver Transplantation for HCV Related End-Stage Liver Disease . Study of Humoral Anti-HCV Response |
blood
Estimated Enrollment: | 300 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | September 2023 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
patients with resolved infection
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2
chronically infected patients
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
patients with resolved infection chronically infected patients
Inclusion Criteria:
Exclusion Criteria:
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 |
France | |
Service d'Hépato-Gastro-Entérologie - Hôpital Civil | Recruiting |
Strasbourg, France, 67000 | |
Contact: Michel DOFFOEL, MD 00 333 88 11 62 49 michel.doffoel@ chru-strasbourg.fr | |
Principal Investigator: Michel DOFFOEL, MD | |
Sub-Investigator: Ahmed ANANNA, MD | |
Sub-Investigator: François HABERSETZER, MD | |
Service d'Hématologie et Oncologie - Hôpital de Hautepierre | Recruiting |
Strasbourg, France | |
Contact: Albert FARADJI, MD 00333.88.12.76 90 albert.faradji@ chru-strasbourg.fr | |
Principal Investigator: Albert FARADJI, MD | |
Service de Chirurgie Générale et Transplantation Multiorganes - Hôpital de Hautepierre | Not yet recruiting |
Strasbourg, France | |
Contact: Philippe WOLF, MD 00333 88 12 72 78 philippe.wolf@chru-strasbourg.fr | |
Principal Investigator: Philippe WOLF, MD | |
Sub-Investigator: Bernard ELLERO, MD | |
Sub-Investigator: Marie-Lorraine WOEHL-JAEGLE, MD |
Principal Investigator: | Michel DOFFOEL, MD | CHRU Strasbourg |
Principal Investigator: | Albert FARADJI, MD | CHRU Strasbourg |
Principal Investigator: | Philippe WOLF, MD | CHRU Strasbourg |
Responsible Party: | CHU Strasbourg ( Emmanuel Lavoué Directeur adjoint de la recherche clinique et de l'innovation ) |
Study ID Numbers: | 4109 |
Study First Received: | March 3, 2008 |
Last Updated: | March 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00638144 |
Health Authority: | France :Ministère de la recherche |
Hepatitis C liver transplantation antibodies mediated neutralization monoclonal antibodies |
Antibodies, Monoclonal Virus Diseases Hepatitis Antibodies Liver Diseases |
Digestive System Diseases Hepatitis, Viral, Human Hepatitis C Antibodies Hepatitis C Immunoglobulins |
RNA Virus Infections Immunologic Factors Flaviviridae Infections Physiological Effects of Drugs Pharmacologic Actions |