Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,500
- 试验地点
- 12
- 主要终点
- Number of plot samples collected
研究概览
简要总结
The " CirB-RNA " cohort aims to create a biological collection associated with clinical and biological data from patients with hepatitis B infection. This project is part of a much larger program that aims to characterize and quantify circulating viral RNAs as a possible new biomarker of hepatitis B functional cure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Adults patients and minor children over 6 years of age (in Lyon) with acute or chronic hepatitis B or presenting with HBsAg loss (with/without HBs seroconversion). (Co-infected patients with HDV and/or HCV and/or HIV are eligible)
- •Patients requiring blood sampling for medical care at the time of the medical appointment.
- •Informed patients who do not refuse to participate.
- •Persons not affiliated to a social security scheme and persons receiving medical assistance from the state may be asked to participate in the study
排除标准
- •Patients participating at the time of the inclusion to an interventional trial evaluating a drug likely to interfere with this study.
- •Persons deprived of their liberty by a judicial or administrative decision
- •Adults who are subject to a legal protection measure
- •Children less than 6 years old (in Lyon)
结局指标
主要结局
Number of plot samples collected
时间窗: maximum 46 months
The aim of this study is the constitution of a cohort with biological collection associated with clinical and biological data Data and samples will be collected at each follow-up visit until end of project (longitudinal study). This cohort is the first step of a research program and will be use in further study which are part of this research program. All studies of this research program aim to improve knowledge about hepatitis B, develop and validate a new biomarker of hepatitis B cure.
次要结局
未报告次要终点