SOF/VEL±RBV: Real-World Efficacy and Safety in GT 3 and 6 HCV Patients in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- SVR12
研究概览
简要总结
150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated patients will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered Epclusa each plus Ribavirin for 12 weeks.
详细描述
This is a Prospective, observational, multi-center, real-world study to investigate real world effectiveness and safety of SOF/VEL±RBV in Chinese patients infected by HCV GT-3 and 6. 150 GT3 or GT6 CHC patients with or without compensated cirrhosis will be recruited from five centers in China including G3a 50, G3b 50, G6 50 respectively. GT3a and GT6 CHC with or without compensated cirrhosis will be administered one pill of Epclusa each day for 12 weeks, and GT3b patients will be administered one pill of Epclusa each plus Ribavirin for 12 weeks.Demographic, clinical, adverse event and virological data were be collected throughout treatment and post-treatment follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV RNA ≥ 15 IU/Ml at Screening
- •HCV genotype 3a ,3b and 6
- •Hepatitis C without decompensated cirrhosis of the liver
排除标准
- •Patients failed to previous NS5A-containing DAAs therapy
- •Decompensated cirrhosis
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
研究组 & 干预措施
genotype 3a HCV
genotype 3a hepatitis C
干预措施: Epclusa (sofosbuvir and velpatasvir) (Drug)
genotype 6 HCV
genotype 6 hepatitis C
干预措施: Epclusa (sofosbuvir and velpatasvir) (Drug)
genotype 3b HCV
genotype 3b hepatitis C
干预措施: Epclusa (sofosbuvir and velpatasvir) (Drug)
结局指标
主要结局
SVR12
时间窗: 12 weeks
HCV RNA \<LLOQ at Week 12 after cessation of treatment
次要结局
未报告次要终点
研究者
Zhe-bin Wu
Professor
Third Affiliated Hospital, Sun Yat-Sen University