Clinical Impacts of Achieving Sustained Virological Response in Patients With Advanced Hepatic Fibrosis Related to Chronic HCV Treated With Direct Acting Antivirals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
- 主要终点
- Detection of HCC by CT
研究概览
简要总结
Chronic HCV infection has relatively slow rate of progression. Liver fibrosis is the main sequlae and usually progressed to cirrhosis after long period (10 to 20 years) [6]. Once cirrhosis is established the disease progression remains unpredictable: cirrhosis can remain indolent for many years in some patients whilst progressing in others to HCC, hepatic decompensation and death. Overall once cirrhosis has developed there is a 1-5% annual risk of HCC and a 3-6% annual risk of hepatic decompensation. Following an episode of decompensation the risk of death in the following year is between 15% and 20% Treatment of chronic HCV has been dramatically changed in the last few years with introduction of direct acting antivirals (DAAs). The new therapies with excellent safety profiles, shorter duration of therapy and marked higher efficacy can be even used in patients with advanced fibrosis and cirrhosis
详细描述
Chronic HCV infection has relatively slow rate of progression. Liver fibrosis is the main sequlae and usually progressed to cirrhosis after long period (10 to 20 years) [6]. Once cirrhosis is established the disease progression remains unpredictable: cirrhosis can remain indolent for many years in some patients whilst progressing in others to HCC, hepatic decompensation and death. Overall once cirrhosis has developed there is a 1-5% annual risk of HCC and a 3-6% annual risk of hepatic decompensation. Following an episode of decompensation the risk of death in the following year is between 15% and 20% Treatment of chronic HCV has been dramatically changed in the last few years with introduction of direct acting antivirals (DAAs). The new therapies with excellent safety profiles, shorter duration of therapy and marked higher efficacy can be even used in patients with advanced fibrosis and cirrhosis
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •above 12 years old
- •fibroscan F3 or F4
- •HCV positive
- •Received DAAs
排除标准
- •below 12 years old
- •fibroscan below F3
- •HCV negative
研究组 & 干预措施
DAAs-SVR.
annual incidence of HCC in chronic hepatitis C patients with advanced liver fibrosis (F3 and F4) after achieving DAAs-SVR.
干预措施: DAAs (Drug)
结局指标
主要结局
Detection of HCC by CT
时间窗: 12-45 months after SVR
incidence of HCC in chronic hepatitis C patients with advanced liver fibrosis (F3 and F4) after achieving DAAs-SVR
次要结局
- fibrosis stage changes by Fibroscan(12-45 months after SVR)
