A Randomized, Placebo-controlled, Phase 2a Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 10
- 主要终点
- Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
研究概览
简要总结
Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment-naive subjects with genotype 1 chronic HCV
- •HCV RNA ≥ 100,000 IU/mL at screening
- •Seronegative for HIV and HBsAg
- •Liver biopsy within prior 2 years demonstrating no cirrhosis
排除标准
- •Any evidence of liver disease other than hepatitis C
- •Diagnosed or suspected hepatocellular carcinoma
- •Laboratory values: neutrophil count < 1500 cells/μL, platelet count < 90,000/μL; Hemoglobin ≤ 12 g/dL (120g/L) for women and ≤ 13 g/dL (130 g/L) for men
- •Cirrhosis
研究组 & 干预措施
BMS-824393 (10mg)
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
干预措施: BMS-824393 (Drug)
BMS-824393 (10mg)
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
干预措施: Peginterferon Alpha-2a (Drug)
BMS-824393 (10mg)
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
干预措施: Ribavirin (Drug)
BMS-824393 (30 mg)
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
干预措施: BMS-824393 (Drug)
BMS-824393 (30 mg)
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
干预措施: Peginterferon Alpha-2a (Drug)
BMS-824393 (30 mg)
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
干预措施: Ribavirin (Drug)
BMS-824393 (100 mg)
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
干预措施: BMS-824393 (Drug)
BMS-824393 (100 mg)
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
干预措施: Peginterferon Alpha-2a (Drug)
BMS-824393 (100 mg)
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
干预措施: Ribavirin (Drug)
Placebo
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
干预措施: Placebo (Drug)
Placebo
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
干预措施: Peginterferon Alpha-2a (Drug)
Placebo
Plus Peginterferon Alfa-2a and Ribavirin
Day 1 - Week 12
干预措施: Ribavirin (Drug)
Peginterferon alfa-2a plus Ribavirin
Weeks 13 - 48
干预措施: Peginterferon Alpha-2a (Drug)
Peginterferon alfa-2a plus Ribavirin
Weeks 13 - 48
干预措施: Ribavirin (Drug)
结局指标
主要结局
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
时间窗: Week 48
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA
时间窗: Week 12
次要结局
- Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA(Week 4)
- Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA(Week 12)
- Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable(Week 24 (SVR24))
- Resistant variants associated with virologic failure(Week 24)