Effect of Entecavir Treatment on Regression and Long-term Disease Outcome in Patients With HBV-induced Liver Fibrosis and Cirrhosis (Regress Extension Study)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
- 试验地点
- 20
- 主要终点
- Fibrosis regression rate
研究概览
简要总结
Patients who have completed 2 years follow-up of the past National 12th Five-Year Major Project on Infectious Diseases will receive another 8 years treatment with entecavir (10 years in total). Collect serology, imaging, and other clinical data to evaluate the incidence and mortality of decompensated cirrhosis and hepatocellular carcinoma. Understand the effects of long-term antiviral therapy on HBV-induced liver fibrosis/cirrhosis.
详细描述
Patients who have completed 2-years entecavir-based treatment in Regress Study will receive another 8 years of entecavir extension therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBV-DNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan; A third liver biopsy will be performed at the 5th year of treatment in patients who have significant fibrosis at second biopsy. CT /MRI and endoscopy will be performed at baseline and the 5th and 10th year of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects who completed the 2 years of entecavir-based therapy in Regress study; Subjects who are willing to participate the extension study.
排除标准
- •Any complication of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases; Pregnant women; Subjects who could not compliance with the protocol judged by investigators; Subjects who are not suitable for the study judged by investigators.
研究组 & 干预措施
Treatment group
entecavir oral，0.5mg daily for 8 years
干预措施: Entecavir (Drug)
结局指标
主要结局
Fibrosis regression rate
时间窗: year 3
Ishak fibrosis score decrease after long-term treatment
Cumulative incidence of liver decompensation
时间窗: year 8
Cumulative incidence of liver decompensation (including ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) and death after long-term treatment
次要结局
- Virological response(year 3, 5, 7 and 10)
- Aminotransferase response(year 3, 5, 7 and 10)
- HBeAg loss or HBeAg seroconversion(year 2, 5, 7 and 10)
- HBsAg loss or HBsAg seroconversion rate(year 2, 5, 7 and 10)
- Dynamic changes of Child-Pugh score(year 3, 5, 7 and 10)
- Dynamic changes of MELD score(year 3, 5, 7 and 10)
- Dynamic changes of liver stiffness values measured by Transient Elastography(year 3, 5, 7 and 10)
- Improvement of life quality (SF36 and EQ-5D)(year 3, 5, 7 and 10)
研究者
Xiaojuan Ou
Vice-Director of Liver Research Center
Beijing Friendship Hospital