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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2018-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Transplantation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with alcoholic or hepatitis C virus related disease

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

cccDNA assay on liver biopsy

Intervention Type BIOLOGICAL

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

Hepatitis B core antibody positive donors

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

cccDNA assay on liver biopsy

Intervention Type BIOLOGICAL

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

HBV patients

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

cccDNA assay on liver biopsy

Intervention Type BIOLOGICAL

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

Interventions

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cccDNA 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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No