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

NCT00638144 | Unknown

• 1 other identifier: 4109
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatitis C

Keywords

Hepatitis C; liver transplantation; antibodies mediated neutralization; monoclonal antibodies

Study Arms (2)

1

patients with resolved infection

2

chronically infected patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with resolved infection chronically infected patients

You may qualify if:

• 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

You may not qualify if:

• Immunosuppression
• HBV or HIV infection
• Pregnancy
• Breast feeding

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (3)

Service d'Hépato-Gastro-Entérologie - Hôpital Civil

Strasbourg, 67000, France

RECRUITING

Service d'Hématologie et Oncologie - Hôpital de Hautepierre

Strasbourg, France

RECRUITING

Service de Chirurgie Générale et Transplantation Multiorganes - Hôpital de Hautepierre

Strasbourg, France

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Michel DOFFOEL, MD

  CHRU Strasbourg

  PRINCIPAL INVESTIGATOR

• Albert FARADJI, MD

  CHRU Strasbourg

  PRINCIPAL INVESTIGATOR

• Philippe WOLF, MD

  CHRU Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BAUMERT Thomas, MD

CONTACT

00 333 90 24 36 99; thomas.baumert@chru-strasbourg.fr

Françoise STOLL-KELLER, MD

CONTACT

00 333 90 24 37 16; francoise.stoll@viro-ulp.u-strasbg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 18, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 30, 2015

Record last verified: 2015-09

Locations

FR (3)