Study of Covalently Closed Circular DNA (cccDNA) in Liver Transplant Patients With B Virus Markers
- Conditions
- Liver Transplantation
- Interventions
- Biological: cccDNA assay on liver biopsy
- Registration Number
- NCT02602847
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with alcoholic or hepatitis C virus related disease cccDNA assay on liver biopsy cccDNA assay on liver biopsy in patients with liver transplantation for alcoholic disease or hepatitis C virus (HCV) related disease, without contact with HBV Hepatitis B core antibody positive donors cccDNA assay on liver biopsy cccDNA assay on liver biopsy in patients who receive liver from hepatitis B core antibody positive donors HBV patients cccDNA assay on liver biopsy cccDNA assay on liver biopsy in patient with liver transplantation for chronic hepatitis B, with or without HBV replication
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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
Trial Locations
- Locations (5)
CHU Grenoble
馃嚝馃嚪La Tronche, France
CHU de Nice
馃嚝馃嚪Nice, France
Service d'H茅patologie, H么pital de la Croix-Rousse
馃嚝馃嚪Lyon, France
H么pital Saint Eloi
馃嚝馃嚪Montpellier, France
H么pital Paul Brousse
馃嚝馃嚪Villejuif, France