Study of Covalently Closed Circular DNA (cccDNA) in Liver Transplant Patients With B Virus Markers (ECOGREFFE-B)

Civil Hospices of Lyon

Status: Completed

Conditions: Liver Transplantation

Treatments: Biological: cccDNA assay on liver biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT02602847

2012.720

Details and patient eligibility

About

The aim of this study is to validate in the context of liver transplantation, the interest of the cccDNA assay technique developed by the team of Professor Zoulim (INSERM U1052) on liver biopsy and correlate this assay cccDNA in hepatitis B virus (HBV) viral load and serum liver through several groups of patients at transplantation (on graft and native liver explant) and after transplantation.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient registered on the national Organ Transplant Waiting List for liver transplantation
• Indication of transplantation :
• Alcoholic related disease without serum anti-hepatitis B core antibody (HBc) (less than 4 weeks) OR - HCV related disease without serum anti-HBc antibody (less than 4 weeks) OR - Patients who sign consent for liver transplantation from hepatitis B core antibody positive donors OR - HBV related disease with positive serum HBs antigen (with or without HBV replication measured by polymerase chain reaction (PCR) within 6 months prior transplantation)
• Signed consent form
• Patient with a social cover
• Patient not covered by any measure of legal protection

Exclusion criteria

• Co-infection with HIV, hepatitis delta virus (HDV), HBV (for control arm), HCV (for Test arm) - Positive serology within the4 weeks before inclusion
• Patient covered by any measure of legal protection
• informed consent not signed

Trial design

40 participants in 3 patient groups

Patients with alcoholic or hepatitis C virus related disease

Description:

cccDNA assay on liver biopsy in patients with liver transplantation for alcoholic disease or hepatitis C virus (HCV) related disease, without contact with HBV

Treatment:

Biological: cccDNA assay on liver biopsy

Hepatitis B core antibody positive donors

Description:

cccDNA assay on liver biopsy in patients who receive liver from hepatitis B core antibody positive donors

Treatment:

Biological: cccDNA assay on liver biopsy

HBV patients

Description:

cccDNA assay on liver biopsy in patient with liver transplantation for chronic hepatitis B, with or without HBV replication

Treatment:

Biological: cccDNA assay on liver biopsy