NCT01051414已完成2 期
A Phase 2a Study of BMS-790052 and BMS-650032 in Combination Therapy With Japanese Subjects With Genotype 1 Chronic Hepatitis C (HCV) Virus Infection
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Part 1: To assess safety and tolerability based on 4 weeks safety data, as measured by related serious adverse events (SAEs) and discontinuations due to related AEs
研究概览
简要总结
To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 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
- •HCV RNA viral load of ≥ 10*5* IU/mL (100,000 IU/mL) at screening
排除标准
- •Subjects with evidence of liver cirrhosis
- •Evidence of HCC
- •Co-infection with hepatitis B virus, HIV
研究组 & 干预措施
BMS-790052 + BMS-650032
Experimental
干预措施: BMS-790052 (Drug)
BMS-790052 + BMS-650032
Experimental
干预措施: BMS-650032 (Drug)
结局指标
主要结局
Part 1: To assess safety and tolerability based on 4 weeks safety data, as measured by related serious adverse events (SAEs) and discontinuations due to related AEs
时间窗: Week 4
Part 2: To determine the proportion of subjects who achieve SVR12 (i.e., HCV RNA < 15 IU/mL at follow-up Week 12)
时间窗: Post-treatment Week 12
次要结局
- The proportion of subjects with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL(at both Weeks 4 and 12)
- Resistant variants associated with clinical failure(Weeks 4, 12, end of treatment and post-treatment Week 24)
- The safety of co-administration of BMS-790052 + BMS-650032 as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities(Weeks 4, 12, end of treatment and post-treatment Week 24)
- The proportion of subjects who achieve RVR (defined as HCV RNA < 15 IU/mL(Week 4)
- The proportion of subjects who achieve SVR24 (defined as HCV RNA < 15 IU/mL(at follow-up Week 24)
研究者
研究点 (1)
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