A Nation-wide Hospital-based Hepatitis B Registry:China Registry of Hepatitis B
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200,000
- 试验地点
- 45
- 主要终点
- Rate of liver-related events after antiviral therapy
研究概览
简要总结
CR-HepB registry started in June 30,2012 to collect HBV cases from general hospitals or specialized hospitals for infectious diseases in mainland China. Demographics, diagnosis, laboratory test results, family history and prescriptions were recorded. The main criteria for registration is HBsAg-positivity more than 6 months, and these patients will receive followed-up visits every three to six months.
详细描述
This web-based database was launched on June 30, 2012 and consists of tertiary or secondary hospitals with special interest and expertise on managing hepatitis B patients across mainland China. The main inclusion criteria for this registration are HBsAg-positivity ≥ 6 months, HBeAg positive or negative, with or without cirrhosis, either treatment-naïve or treatment experienced. At the first time of data entry, demographics, medical history, virology, biochemistry and hematology results, radiology reports, diagnosis and treatment information were recorded. Then the registered patients received standard of care and follow-up every 3 to 6 months. On each visit, virological, biochemical, and radiological reports, as well as clinical progress were recorded.
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
- •HBsAg-positivity over a continuous six months.
- •The core exclusion criteria are: 1) HCC patients for their treatment mainly depends on surgical operation and interventional therapy, but not the antiviral therapy; 2) patients who are unable or unwilling to provide informed consent.
排除标准
- 未提供
结局指标
主要结局
Rate of liver-related events after antiviral therapy
时间窗: 10 years
Rates of cirrhosis,decompensation and hepatocellular carcinoma with or without antiviral therapy
次要结局
- The HBV DNA undetectable rate with or without antiviral therapy(10 years)
- HBeAg loss and seroconversion rates with or without antiviral therapy(10 years)
研究者
Jidong Jia
Liver Research Center
Beijing Friendship Hospital