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临床试验/NCT01962155
NCT01962155已完成不适用

Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus

Peking University First Hospital30 个研究点 分布在 1 个国家目标入组 1,841 人开始时间: 2013年8月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guiqiang Wang

MD

Peking University First Hospital

研究点 (30)

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