NCT02602847已完成不适用
Study of cccDNA in Liver Transplant Patients With B Virus Markers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- cccDNA rate on native explant and liver transplant during transplantation and on liver biopsy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
cccDNA rate on native explant and liver transplant during transplantation and on liver biopsy
时间窗: 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
次要结局
- 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)
研究者
研究点 (5)
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