NCT02392598Unknown不适用
Effect of Hepatic Steatosis on Prognosis and Outcomes of Patients With Chronic Hepatitis B
Fatty Liver and Alcoholic Liver Disease Study Group, China7 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2015年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 7
- 主要终点
- liver cirrhosis
研究概览
简要总结
This is an epidemiologic study on effect of hepatic steatosis on prognosis and outcomes of patients with chronic hepatitis B.
详细描述
This is a multicenter, prospective and open-enrollment epidemiologic study. All the patients with chronic hepatisis B will be enrolled in the study and followed up after 1 year, 3 years and 5 years with a visit window of +1 month.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed chronic hepatitis B.
- •Specific biopsy requirements for hepatic steatosis: qualified biopsy specimen within 6 months, >5% hepatocytes show macrovesicular steatosis under HE staining and X10 microscope.
- •Willing to participate in the long-term follow-up and cooperative.
- •Able to provide informed consent file.
排除标准
- •Unable to provide informed consent.
- •Patients are eligible for baseline analysis but not eligible for follow-up, if having any of the following condition:
- •Any end-stage liver disease.
- •Any malignant tumor.
- •Any congenital liver disease such as Wilson disease.
- •Any other serious disease of projected survival < 5 years.
结局指标
主要结局
liver cirrhosis
时间窗: 5 years
次要结局
- effect of hepatic steatosis on HBeAg negativation among patients without anti-virus treatment(1 year)
- response of hepatic steatosis to anti-virus treatment(1 year)
- effect of hepatic steatosis on HBsAg negativation among patients without anti-virus treatment(1 year)
- liver cancer(5 years)
- cardiovascular and cerebrovascular events(5 years)
- liver failure(5 years)
- type 2 diabetes(5 years)
- death(5 years)
研究者
研究点 (7)
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