Liver Transplantation
Conditions
Keywords
Liver transplantation, HBV, cccDNA
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.
Interventions
BIOLOGICALcccDNA assay on liver biopsy
cccDNA assay will be performed on liver biopsies at different times : During transplantation : Liver biopsy of explant and graft and virological biology Between M1 to M3 after transplantation : Liver biopsy between 1 to 3 months after transplantation M12 : Liver biopsy 12 months after transplantation
Sponsors
Hospices Civils de Lyon
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cccDNA rate on native explant and liver transplant during transplantation and on liver biopsy | 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
| Measure | Time frame | Description |
|---|---|---|
| Correlation between cccDNA rate and serologic status | 1 year after transplantation | Correlation of cccDNA rate with serologic and virologic status (AgHBe, HBV DNA, ...) at the moment of the transplantation and during post-transplantation period and HBV recurrence |
| Correlation between cccDNA rate and virologic status | 1 year after transplantation | Correlation of cccDNA assay with serologic and virologic status (AgHBe, HBV DNA, ...) will be assessed at the moment of the transplantation and during post-transplantation period and HBV recurrence |
| Correlation between cccDNA rate and patient's treatment | 1 year after transplantation | Correlation of cccDNA rate with patients' treatments will be assessed at the moment of the transplantation and during post-transplantation period and HBV recurrence |
Countries
France
Outcome results
None listed