Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Kinetic cccDNA
研究概览
简要总结
Serum HBV DNA is a referent but insufficient marker of therapeutic follow-up in chronic hepatitis B treatment. Intra hepatic cccDNA disappearance reflects HBV eradication in the liver.
Intra lymphocyte cccDNA could be a new marker of HBV eradication after treatment.
The major interest of this marker is that it can be measured by a simple blood test instead of a liver biopsy.
详细描述
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Studying intra lymphocyte and blood cccDNA: before inclusions, D0 then each month during the first three months each three months during treatment and follow-up.
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Viral kinetics:Before inclusions, at D0, then monthly till the end of treatment and follow-up: Evolution of quantitative viraemia in serum Evolution of quantitative viraemia in circulating lymphocytes Evolution of quantitative viraemia in total blood
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Studying viral genotypes
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients >18 years of age and <70 years of age
- •Patients AgHbs+ and AgHbe+ or AgHbe-, and B viral DNA >104 copies/ml PCR COBAS MONITOR
- •Patients treated with adefovir dipivoxil and peg interferon alpha 2a
- •Chronic liver disease consistent with chronic hepatitis B infection on a biopsy obtained within the past 24 months
- •Naïve patients or patients having a relapse or a therapeutic failure after monotherapy lamivudine or interferon, or bitherapy interferon alpha-lamivudine
排除标准
- •Co-infection HIV, HCV
结局指标
主要结局
Kinetic cccDNA
时间窗: 6 months
Studying the kinetics of cccDNA in cells and whole blood
次要结局
未报告次要终点