A Phase 2a Study of Daclatasvir in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Extended Rapid Virologic Response (eRVR)
研究概览
简要总结
The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects chronically infected with hepatitis C virus (HCV) genotype 1
- •HCV RNA viral load ≥ 10*5* IU/mL (100,000 IU/mL) at screening
- •The current standard of care naïve or non-responder
排除标准
- •Cirrhosis
- •Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2
研究组 & 干预措施
Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
干预措施: Daclatasvir (Drug)
Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
干预措施: Peginterferon alfa-2a (Drug)
Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
干预措施: Ribavirin (Drug)
Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
干预措施: Daclatasvir (Drug)
Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
干预措施: Peginterferon alfa-2a (Drug)
Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
干预措施: Ribavirin (Drug)
Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
干预措施: Placebo (Drug)
Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
干预措施: Peginterferon alfa-2a (Drug)
Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
干预措施: Ribavirin (Drug)
Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)
Non-Responder
干预措施: Daclatasvir (Drug)
Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)
Non-Responder
干预措施: Peginterferon alfa-2a (Drug)
Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)
Non-Responder
干预措施: Ribavirin (Drug)
Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Non-Responder
干预措施: Daclatasvir (Drug)
Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Non-Responder
干预措施: Peginterferon alfa-2a (Drug)
Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Non-Responder
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
时间窗: From Week 4 up to Week 12
eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA \<15 IU/mL, the lower limit of detection at both Weeks 4 and 12.
次要结局
- Percentage of Participants With Rapid Virologic Response (RVR)(Week 4)
- Percentage of Participants With a Complete Early Virologic Response (cEVR)(Week 12)
- Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24(Follow up Week 12, Follow up Week 24)