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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):

Study Description
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.

Condition or disease
Hepatitis C

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
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
Study Start Date : February 2008
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
patients with resolved infection
2
chronically infected patients


Outcome Measures

Biospecimen Retention:   Samples Without DNA
blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00638144     History of Changes
Other Study ID Numbers: 4109
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015

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
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs