"Real-life" Cohort Study on Patients With Chronic Hepatitis B Virus Infection in Jiangsu
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20,000
- 试验地点
- 6
- 主要终点
- Hepatic decompensation
研究概览
简要总结
Hepatitis B virus (HBV) infection remains one of the most serious health problems worldwide. Patients with chronic HBV infection are at an increased risk for developing hepatic cirrhosis, hepatocellular carcinoma and even death. Although some predictive factors of the outcome of chronic HBV infection were identified, more precisely determine the factors which are associated with the outcome in non-selected patients with chronic HBV infection are still needed. The investigators purpose is to constitute a observational cohort of non-selected Chinese patients to create a database of epidemiological, clinical, biological, virological, immunologic and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.
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
- •Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)
排除标准
- •Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or hepatitis D virus (HDV)
- •History of liver transplantation
- •History of hepatocellular carcinoma (HCC)
结局指标
主要结局
Hepatic decompensation
时间窗: 20 years
Development of hepatic decompensation will be defined by any of the following events: (1) Ascites or hepatic hydrothorax; (2)Variceal or portal hypertensive bleeding; (3)Hepatic encephalopathy
Number of participants with antigen loss (HBeAg and HBsAg loss)
时间窗: 20 years
Cirrhosis
时间窗: 20 years
Hepatocellular carcinoma (HCC)
时间窗: 20 years
The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.
Death
时间窗: 20 years
Date and cause of death will be recorded.
次要结局
未报告次要终点
研究者
Chao Wu
Prof.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School