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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Hepatitis B core antibody positive donors | cccDNA assay on liver biopsy in patients who receive liver from hepatitis B core antibody positive donors |
| |
| HBV patients | cccDNA assay on liver biopsy in patient with liver transplantation for chronic hepatitis B, with or without HBV replication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cccDNA assay on liver biopsy | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| cccDNA rate on native explant and liver transplant during transplantation and on liver biopsy | 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 | 1 year after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between cccDNA rate and serologic status | 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 | 1 year after transplantation |
| Correlation between cccDNA rate and virologic status |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with liver transplantation planned
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| Name | Affiliation | Role |
|---|---|---|
| Fabien ZOULIM, MD, PhD | Service d'Hépatologie, Hôpital Croix-Rousse, Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble | La Tronche | 38700 | France | |||
| Service d'Hépatologie, Hôpital de la Croix-Rousse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37879886 | Derived | Testoni B, Scholtes C, Plissonnier ML, Paturel A, Berby F, Facchetti F, Villeret F, Degasperi E, Scott B, Hamilton A, Heil M, Lampertico P, Levrero M, Zoulim F. Quantification of circulating HBV RNA expressed from intrahepatic cccDNA in untreated and NUC treated patients with chronic hepatitis B. Gut. 2024 Mar 7;73(4):659-667. doi: 10.1136/gutjnl-2023-330644. | |
| 37122357 |
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|
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 |
| 1 year after transplantation |
| Correlation between cccDNA rate and patient's treatment | Correlation of cccDNA rate with patients' treatments will be assessed at the moment of the transplantation and during post-transplantation period and HBV recurrence | 1 year after transplantation |
| Lyon |
| 69004 |
| France |
| Hôpital Saint Eloi | Montpellier | 34295 | France |
| CHU de Nice | Nice | 06202 | France |
| Hôpital Paul Brousse | Villejuif | 94804 | France |
| Villeret F, Lebosse F, Radenne S, Samuel D, Roche B, Mabrut JY, Leroy V, Pageaux GP, Anty R, Thevenon S, Ahmed SS, Hamilton A, Heil M, Scholtes C, Levrero M, Testoni B, Zoulim F; ECOGREFFE Study Group. Early intrahepatic recurrence of HBV infection in liver transplant recipients despite antiviral prophylaxis. JHEP Rep. 2023 Mar 10;5(6):100728. doi: 10.1016/j.jhepr.2023.100728. eCollection 2023 Jun. |