A Phase2/3, Multi-center, Randomized, Double-blind, Placebo-parallel Controlled Study to Investigate the Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Genotype 1 Infected Subjects.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 425
- 试验地点
- 1
- 主要终点
- Percentage of Participants achieving sustained Virologic response 12 weeks after EOT
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Ravidasvir in combination with Danoprevir/r and ribavirin(RBV) by sustain virologic response 12 (SVR12), in treatment-naive, non-cirrhotic, chronic hepatitis C genotype 1 infected patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Infection with Chronic hepatitis C genotype 1confirmed at screening;
- •Anti-HCV positive；
- •HCV RNA ≥1 × 10000IU / mL;
- •Not treated with interferon and / or any other direct-acting antiviral (DAA) drug;
- •Non-cirrhotic;
- •Voluntarily sign informed consent.
排除标准
- •HCV genotypes 2 to 7 or undetectable HCV genotype or mixed HCV genotype;
- •Fibroscan detection result > 12.9kPa or Histopathological examination result of patients is with cirrhosis;
- •Past or existing evidence of the presence of non-HCV-induced chronic liver disease;
- •Previous history of hepatocellular carcinoma, or suspected hepatocellular carcinoma found prior to screening, or suspected abdominal hepatoblastoma at screening or AFP>100ng/mL;
- •Anti-HAV (IgM) 、HBsAg 、anti-HEV (IgM) or anti-HIV is positive;
- •BMI<18 or≥30 kg/m2;
- •ANC<1.5×109/L、PLT<100×109/L、HB<110g/L（female）or<120g/L（male）；INR>1.5；ALT or AST≥5*ULN；TBIL≥2*ULN（DBIL≥ 35%TBIL）；Cr≥1.5*ULN;
- •Others as specified in detailed protocol.
研究组 & 干预措施
Experimental Group
Ravidasvir + Danoprevir + Ritonavir + Ribavirin
干预措施: Ravidasvir (Drug)
Experimental Group
Ravidasvir + Danoprevir + Ritonavir + Ribavirin
干预措施: Danoprevir (Drug)
Experimental Group
Ravidasvir + Danoprevir + Ritonavir + Ribavirin
干预措施: Ritonavir (Drug)
Experimental Group
Ravidasvir + Danoprevir + Ritonavir + Ribavirin
干预措施: Ribavirin 100 MG (Drug)
Placebo Group
Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo
干预措施: Ravidasvir Placebo (Drug)
Placebo Group
Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo
干预措施: Danoprevir Placebo (Drug)
Placebo Group
Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo
干预措施: Ritonavir Placebo (Drug)
Placebo Group
Ravidasvir placebo + Danoprevir placebo + Ritonavir placebo + Ribavirin placebo
干预措施: Ribavirin Placebo (Drug)
结局指标
主要结局
Percentage of Participants achieving sustained Virologic response 12 weeks after EOT
时间窗: Post treatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks after cessation of therapy
Adverse events leading to permanent discontinuation of study drug
时间窗: baseline to week 12
次要结局
- Percentage of Participants achieving sustained Virologic response 24 weeks after EOT(Post treatment Week 24)
- Quatitation change of HCV RNA compared to baseline after treatment(Baseline to week 1)
- Percentage of participants with viral breakthrough(Baseline to week 12)
- Percentage of participants with viral relapse(End of treatment to post-treatment week 24)
- Percentage of Participants achieving sustained Virologic response 4 weeks after EOT(Post treatment Week 4)