Prevention of Graft Reinfection After Liver Transplantation With Anti HCV Monoclonal Antibodies Identified in Chronically Infected Patients or in Patients With Resolved Hepatitis C

NCT ID: NCT00638144

Last Updated: 2015-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

patients with resolved infection

No interventions assigned to this group

2

chronically infected patients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel DOFFOEL, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Strasbourg

Albert FARADJI, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Strasbourg

Philippe WOLF, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Strasbourg

Locations

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Service d'Hépato-Gastro-Entérologie - Hôpital Civil

Strasbourg, , France

Site Status RECRUITING

Service d'Hématologie et Oncologie - Hôpital de Hautepierre

Strasbourg, , France

Site Status RECRUITING

Service de Chirurgie Générale et Transplantation Multiorganes - Hôpital de Hautepierre

Strasbourg, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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BAUMERT Thomas, MD

Role: CONTACT

00 333 90 24 36 99

Françoise STOLL-KELLER, MD

Role: CONTACT

00 333 90 24 37 16

Facility Contacts

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Michel DOFFOEL, MD

Role: primary

00 333 88 11 62 49

Albert FARADJI, MD

Role: primary

00333.88.12.76 90

Philippe WOLF, MD

Role: primary

00333 88 12 72 78

Other Identifiers

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4109

Identifier Type: -

Identifier Source: org_study_id

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