Study of cccDNA in Liver Transplant Patients With B Virus Markers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 40
- Locations
- 5
- Primary Endpoint
- cccDNA rate on native explant and liver transplant during transplantation and on liver biopsy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
cccDNA rate on native explant and liver transplant during transplantation and on liver biopsy
Time Frame: 1 year after transplantation
cccDNA rate will be assessed on native explant and liver transplant during transplantation and on liver biopsy (between M1 to M3 and 12 months (M12) after transplantation) to study the colonization of new hepatocytes by HBV
Secondary Outcomes
- Correlation between cccDNA rate and virologic status(1 year after transplantation)
- Correlation between cccDNA rate and serologic status(1 year after transplantation)
- Correlation between cccDNA rate and patient's treatment(1 year after transplantation)