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 because the information has not been verified recently.
Verified June 2012 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014