A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Treatment-Naive and IFN Experienced Subjects With Genotype 1 Chronic Hepatitis C
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 297
- 试验地点
- 1
- 主要终点
- Proportion of treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12
研究概览
简要总结
The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA < LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than SVR12 of current Standard of Care (SOC).
详细描述
Limit of Quantitation (LOQ)
Ribonucleic acid (RNA)
End of Treatment (EOT)
Triple Direct Acting Antivirals (3DAA)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, ≥ 20 years of age
- •Subjects chronically infected with HCV GT-1
- •HCV RNA viral load of ≥ 100,000 IU/mL
排除标准
- •Hepatocellular carcinoma
- •Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
- •Severe or uncontrollable complication
研究组 & 干预措施
Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV
DCV 3DAA tablet orally twice daily for 12 weeks + Placebo for DCV tablet orally once daily and Placebo for ASV capsule orally twice daily for 24 weeks (Double blind)
干预措施: DCV 3DAA (Drug)
Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV
DCV 3DAA tablet orally twice daily for 12 weeks + Placebo for DCV tablet orally once daily and Placebo for ASV capsule orally twice daily for 24 weeks (Double blind)
干预措施: Placebo for Daclatasvir (Other)
Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV
DCV 3DAA tablet orally twice daily for 12 weeks + Placebo for DCV tablet orally once daily and Placebo for ASV capsule orally twice daily for 24 weeks (Double blind)
干预措施: Placebo for Asunaprevir (Other)
Arm 2: DCV/ASV + Placebo for DCV 3DAA
Daclatasvir 60 mg tablet orally once daily and Asunaprevir 100 mg capsule orally twice daily for 24 weeks + Placebo for DCV 3DAA tablet orally twice daily for 12 weeks (Double blind)
干预措施: Daclatasvir (Drug)
Arm 2: DCV/ASV + Placebo for DCV 3DAA
Daclatasvir 60 mg tablet orally once daily and Asunaprevir 100 mg capsule orally twice daily for 24 weeks + Placebo for DCV 3DAA tablet orally twice daily for 12 weeks (Double blind)
干预措施: Asunaprevir (Drug)
Arm 2: DCV/ASV + Placebo for DCV 3DAA
Daclatasvir 60 mg tablet orally once daily and Asunaprevir 100 mg capsule orally twice daily for 24 weeks + Placebo for DCV 3DAA tablet orally twice daily for 12 weeks (Double blind)
干预措施: Placebo for DCV 3DAA (Other)
DCV 3DAA
DCV 3DAA (open label) Tablet orally twice daily for 12 weeks
干预措施: DCV 3DAA (Drug)
结局指标
主要结局
Proportion of treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12
时间窗: After 12 weeks of the last dose
次要结局
- The proportion of Interferon (IFN) experienced subjects who achieve SVR12 with DCV/ASV/BMS-791325(Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24)
- The proportion of subjects with anemia defined as Hb < 10 g/dL on-treatment who had Hb ≥ 10 g/dL at baseline(Approximately 48 weeks)
- The proportion of subjects who achieve HCV RNA < LOQ TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)(Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24)
- The proportion of subjects in each cohort who achieve SVR12 associated with HCV genotype subtype 1a vs 1b(Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24)
- On-treatment safety of non-cirrhotic vs cirrhotic subjects, as measured by the frequency of SAEs, discontinuations due to AEs, and selected Grade 3 - 4 laboratory abnormalities on DAIDS criteria(Approximately 48 weeks)
- The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV(Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24)
- The proportion of subjects who achieve HCV RNA < LOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4, 8, 12 and 24(Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24)
- On-treatment safety as measured by the frequency of Serious Adverse Event (SAEs), discontinuations due to Adverse Event (AEs), and selected Grade 3 - 4 laboratory abnormalities(Approximately 48 weeks)
- The proportion of subjects in each cohort who achieve SVR12 associated with IL28B Single Nucleotide Polymorphisms (SNP) status(Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24)
- The proportion of cirrhotic and non-cirrhotic subjects who achieve SVR12(Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24)