The Efficacy, Safety and Long-term Prognosis of Glecaprevir/Pibrentasvir in the Treatment of Chronic Hepatitis C Patients in China--A Real-world Study
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 主要终点
- SVR 12
研究概览
简要总结
To evaluate the efficacy, adverse effect, short - and long-term outcomes of Glecaprevir/Pibrentasvir for the treatment of chronic hepatitis C (non-cirrhotic or compensatory cirrhosis)in China through a real-world study
详细描述
This study is a multi-center, prospective, real-world study, aiming to investigate the use of Glecaprevir/Pibrentasvir in routine clinical management of chronic hepatitis C patients and evaluate its effectiveness and safety across a heterogeneous population in China.Approximately 800 patients will take part in this study, 20 sites will be included which distribute in China's major cities, thus each site will enroll 40 patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •Meet the standard of Glecaprevir/Pibrentasvir treatment
排除标准
- •Patients have contraindications to Glecaprevir/Pibrentasvir
- •Pregnancy or lactation
- •Malignancy
- •Decompensatory cirrhosis
研究组 & 干预措施
G/P treatment
Chronic hepatitis C patients who will recieve Glecaprevir/Pibrentasvir treatment
干预措施: Glecaprevir/Pibrentasvir (Drug)
结局指标
主要结局
SVR 12
时间窗: 12 weeks after Glecaprevir/Pibrentasvir treatments
The effectiveness of Glecaprevir/Pibrentasvir treatments and SVR rate 12 weeks after Glecaprevir/Pibrentasvir treatments
progression of Chronic liver disease
时间窗: 5 years after Glecaprevir/Pibrentasvir treatments
Incidence of liver disease progression (such as cirrhosis, decompensation of liver function, liver cancer, liver transplantation, or liver related death)
次要结局
- long term outcome(5 years)
- HRQOL(5 years)