Improvement of Hard Endpoint in Chronic Hepatitis B Patients Treated With Antiviral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Cumulative rate of liver decompensation and/or hepatic carcinoma and/or liver related death
研究概览
简要总结
Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.
详细描述
Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have participated in the research funded by Beijing science and Technology Commission and have completed 156 weeks follow-up.
- •Patients comply with the requirements of the trail voluntarily
- •Written informed consent
排除标准
- •Pregnant woman or patient with severe disease
- •Patients with poor adherence to the study
- •Patients not suitable for the study evaluated by the investigator
研究组 & 干预措施
Anti-viral therapy group
Subjects who have completed the 3 years research "Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis"
干预措施: Nucleos(t)ide Analogues (Drug)
结局指标
主要结局
Cumulative rate of liver decompensation and/or hepatic carcinoma and/or liver related death
时间窗: 10 years
Cumulative rate of liver decompensation (including ascites,hepatic encephalopathy,Gastrointestinal hemorrhage)，and/or hepatocellular carcinoma， and/or liver related death after 10 years of antiviral treatment
次要结局
- HBV-DNA undetectable rate(10 years)
- HBsAg seroconversion rate(10 years)
- Decrease of MELD score(10 years)
- Improvement of life Quality assessed by EQ-5D(10 years)
- HBeAg seroconversion rate(10 years)
- Decrease of Child-Pugh score(10 years)
- Improvement of life Quality assessed by SF-36(10 years)
- Decrease of transient elastography(10 years)
研究者
Jidong Jia
Director of Liver Research Center
Beijing Friendship Hospital