A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2b (PegIntron®) and Ribavirin (Rebetol®) 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
- 51
- 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 is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care
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
- •Patients chronically infected with hepatitis C virus (HCV) genotype 1
- •HCV RNA viral load ≥10*5* IU/mL at screening
- •Naïve or nonresponsive to the current standard of care
排除标准
- •Cirrhosis
- •Hepatocellular carcinoma
- •Coinfection with hepatitis B virus, HIV-1 or HIV-2
研究组 & 干预措施
Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
干预措施: BMS-790052 (Drug)
Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
干预措施: Peginterferon alfa-2b (Drug)
Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
干预措施: Ribavirin (Drug)
Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
干预措施: BMS-790052 (Drug)
Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
干预措施: Peginterferon alfa-2b (Drug)
Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
干预措施: Ribavirin (Drug)
Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
干预措施: Placebo (Drug)
Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
干预措施: Peginterferon alfa-2b (Drug)
Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
干预措施: Ribavirin (Drug)
Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)
Non-Responder
干预措施: BMS-790052 (Drug)
Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)
Non-Responder
干预措施: Peginterferon alfa-2b (Drug)
Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)
Non-Responder
干预措施: Ribavirin (Drug)
Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Non-Responder
干预措施: BMS-790052 (Drug)
Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Non-Responder
干预措施: Peginterferon alfa-2b (Drug)
Arm E (BMS-790052, plus Peginterferon alfa-2b, 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: At Weeks 4 and 12 on treatment
eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.
次要结局
- Percentage of Participants With Rapid Virologic Response (RVR)(At Week 4 on treatment)
- Percentage of Participants With Complete Early Virologic Response (cEVR)(At Week 12 on treatment)
- Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24(Follow-up Weeks 4, 12, and 24)
- Percentage of Participants With Virologic Failure(From on-treatment Week 1 to Follow-up Week 24)