A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 285
- 试验地点
- 16
- 主要终点
- Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs
研究概览
简要总结
The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)
- •Subjects chronically infected with HCV genotype 4 (Phase 2b only)
- •HCV RNA viral load of ≥ 10*5* IU/mL at screening
- •BMI of 18 - 35 kg/m² at screening
排除标准
- •Cirrhosis (Phase 2a only)
- •Decompensated cirrhosis (Phase 2b)
- •Co-infection with HBV or HIV
- •Hepatocellular carcinoma
- •Prior treatment with anti-HCV drugs
研究组 & 干预措施
Phase 2a: Arm 2
干预措施: Ribavirin (Drug)
Phase 2a: Arm 1
干预措施: BMS-650032 (Drug)
Phase 2a: Arm 1
干预措施: Peginterferon Alfa-2a (Drug)
Phase 2a: Arm 1
干预措施: Ribavirin (Drug)
Phase 2a: Arm 2
干预措施: Placebo (Drug)
Phase 2a: Arm 2
干预措施: Peginterferon Alfa-2a (Drug)
Phase 2b: Arm 1
干预措施: BMS-650032 (Drug)
Phase 2b: Arm 1
干预措施: Placebo (Drug)
Phase 2b: Arm 1
干预措施: Peginterferon Alfa-2a (Drug)
Phase 2b: Arm 1
干预措施: Ribavirin (Drug)
Phase 2b: Arm 2
干预措施: Placebo (Drug)
Phase 2b: Arm 2
干预措施: Peginterferon Alfa-2a (Drug)
Phase 2b: Arm 2
干预措施: Ribavirin (Drug)
结局指标
主要结局
Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs
时间窗: 12 weeks after first dose
Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA
时间窗: Week 12
Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA
时间窗: at follow-up Week 24
次要结局
- Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4(Week 4)
- Proportion of HCV genotype 1 subjects with complete early rapid virologic response (eEVR), defined as undetectable HCV RNA at Week 12 (Stage 2 only)(at Week 12 (Stage 2 only))
- Proportion of HCV genotype 1 subjects with early virologic response (EVR) defined as ≥2 log10 decrease in HCV RNA from baseline at Week 12 (Stage 1 only)(Week 12 (Stage 1 only))
- Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12(follow-up Week 12)
- Proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24) defined as undetectable HCV RNA at follow-up Week 24 (Stage 1 only)(follow-up Week 24 (Stage 1 only))
- Resistant variants associated with virologic failure(48 weeks after last dose)