A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-Cirrhotic Subjects Infected With Chronic HCV Genotype 3
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF)
研究概览
简要总结
The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Genotype 3
- •HCV RNA < 2000000 IU/mL
- •Never taken HCV medication
- •Absence of advanced fibrosis or cirrhosis
- •Body mass index (BMI) 18-40 kg/m^2
排除标准
- •Infection with HCV other than genotype 3 (GT3); Mixed infections of any genotype
- •Previously taken HCV medication
- •Liver Cirrhosis
- •Evidence of decompensated liver disease
- •HIV/ hepatitis B virus (HBV) coinfection
研究组 & 干预措施
Daclatasvir + Sofosbuvir
Daclatasvir 60mg tablet and Sofosbuvir 400mg tablet oral dosing once daily for 8 weeks
干预措施: Daclatasvir (Drug)
Daclatasvir + Sofosbuvir
Daclatasvir 60mg tablet and Sofosbuvir 400mg tablet oral dosing once daily for 8 weeks
干预措施: Sofosbuvir (Drug)
Daclatasvir + Sofosbuvir + Ribavirin
Daclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm once daily for 8 weeks
干预措施: Daclatasvir (Drug)
Daclatasvir + Sofosbuvir + Ribavirin
Daclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm once daily for 8 weeks
干预措施: Sofosbuvir (Drug)
Daclatasvir + Sofosbuvir + Ribavirin
Daclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm once daily for 8 weeks
干预措施: Ribavirin (Drug)
结局指标
主要结局
Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF)
时间窗: Post Treatment Follow up Week 12
SVR12 defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects treated with 8 weeks of DCV+SOF therapy or DCV+SOF+RBV therapy
次要结局
- Safety measured by number of incidence of deaths, serious adverse events (SAE)s, discontinuation due to adverse events (AE)s, Grade 3/4 AEs and Grade 3/4 laboratory abnormalities observed from clinical laboratory testing(Approximately 1.5 years)
- Antiviral activity measured by the proportion of subjects who achieve HCV RNA < lower limit of quantification (LLOQ) - at during and after treatment in each treatment arm(Post treatment follow up Week 24)
- Proportion of subjects with CC, CT or TT IL28B genotype who achieve SVR12 in each treatment arm(Post Treatment Follow up Week 12)