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临床试验/NCT01679769
NCT01679769已完成不适用

Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 818 人开始时间: 2012年5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
818
试验地点
1
主要终点
Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy

研究概览

简要总结

The aim of our study is to evaluate liver fibrosis using biochemical markers, FibroScan, and radiology methods in patients with chronic hepatitis B in mainland China.

详细描述

Up to Nov, 2015, total of 818 patients with chronic HBV infection had been enrolled in the study. Paired blood and liver biopsy specimen had been collected. The serum samples stored at -80 degree Celsius. All the liver biopsy samples were judged by three pathology experts, according to Ishak standard.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of chronic hepatitis B or compensated cirrhosis due to chronic hepatitis B virus infection
  • agree to have liver biopsy

排除标准

  • clinical diagnosis of decompensated cirrhosis due to hepatitis B virus or inactive carrier
  • liver diseases due to other origin

结局指标

主要结局

Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy

时间窗: within two weeks after liver biopsy

次要结局

  • Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsy(within two weeks after liver biopsy)

研究者

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

Guiqiang Wang

Professor

Peking University First Hospital

研究点 (1)

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