Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,841
- 试验地点
- 30
- 主要终点
- determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis B
研究概览
简要总结
The aim of our prospective study is to construct and validate a non-invasive model consisting biochemical markers, FibroScan, and radiological parameters for evaluating liver fibrosis caused by hepatitis B virus in mainland China.
详细描述
Up to Oct, 2015,total of 1800 patients with chronic HBV infection were enrolled. Paired blood and liver biopsy samples were collected. Blood samples stored at -80 degree Celsius. Liver biopsy samples were judged by three pathology experts.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBsAg positive for at least 6 months
- •agree to have liver biopsy
- •Male or female aged 18 to 65 years old
排除标准
- •Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease
- •platelet count < 80000/L
- •prothrombin activity ≤ 60%
- •patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
结局指标
主要结局
determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis B
时间窗: singular evaluation at the time of liver biopsy
次要结局
未报告次要终点
研究者
Guiqiang Wang
MD
Peking University First Hospital
