Prevention of Graft Reinfection After Liver Transplantation With Anti HCV Monoclonal Antibodies Identified in Chronically Infected Patients or in Patients With Resolved Hepatitis C
This study is currently recruiting participants.
Verified June 2012 by University Hospital, Strasbourg, France
Sponsor:
University Hospital, Strasbourg, France
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00638144
First received: March 3, 2008
Last updated: June 28, 2012
Last verified: June 2012
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Purpose
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 |
|---|
|
Hepatitis C |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prevention of Graft Reinfection After Liver Transplantation for HCV Related End-stage Liver Disease . Study of Humoral Anti-HCV Response |
Resource links provided by NLM:
Further study details as provided by University Hospital, Strasbourg, France:
Biospecimen Retention: Samples Without DNA
blood
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
patients with resolved infection
|
|
2
chronically infected patients
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
patients with resolved infection chronically infected patients
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638144
Contacts
| Contact: BAUMERT Thomas, MD | 00 333 90 24 36 99 | thomas.baumert@chru-strasbourg.fr |
| Contact: Françoise STOLL-KELLER, MD | 00 333 90 24 37 16 | francoise.stoll@viro-ulp.u-strasbg.fr |
Locations
| 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 | |
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
| Principal Investigator: | Michel DOFFOEL, MD | CHRU Strasbourg |
| Principal Investigator: | Albert FARADJI, MD | CHRU Strasbourg |
| Principal Investigator: | Philippe WOLF, MD | CHRU Strasbourg |
More Information
No publications provided
| Responsible Party: | University Hospital, Strasbourg, France |
| ClinicalTrials.gov Identifier: | NCT00638144 History of Changes |
| Other Study ID Numbers: | 4109 |
| Study First Received: | March 3, 2008 |
| Last Updated: | June 28, 2012 |
| Health Authority: | France :Ministère de la recherche |
Keywords provided by University Hospital, Strasbourg, France:
|
Hepatitis C liver transplantation antibodies mediated neutralization monoclonal antibodies |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C End Stage Liver Disease Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Flaviviridae Infections Liver Failure Hepatic Insufficiency Antibodies Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013