NCT01497834已完成3 期
A Phase 3 Japanese Study of BMS-790052 Plus BMS-650032 Combination Therapy in Chronic Hepatitis C Genotype 1b Infected Subjects Who Are Non Response to Interferon Plus Ribavirin and Interferon Based Therapy Ineligible Naive/Intolerant
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Antiviral activity, as determined by the proportion of subjects with SVR24
研究概览
简要总结
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.
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
- •Chronic HCV-1b infected patient
- •HCV RNA viral load of ≥ 100,000 IU/mL at screening
- •Ages 20 to 75 years
- •Non-responder to Interferon plus Ribavirin therapy
- •Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy
排除标准
- •Patients who have -
- •Hepatocellular carcinoma
- •Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
- •Severe or uncontrollable complication
研究组 & 干预措施
Daclatasvir + Asunaprevir
Experimental
干预措施: BMS-790052 (Daclatasvir) (Drug)
Daclatasvir + Asunaprevir
Experimental
干预措施: BMS-650032 (Asunaprevir) (Drug)
结局指标
主要结局
Antiviral activity, as determined by the proportion of subjects with SVR24
时间窗: After 24 weeks of the last dose
SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)
次要结局
- Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected(Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24)
- Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below lower limit of quantitation (LLOQ) target detected or not detected(Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12)
- Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), AEs by intensity and laboratory abnormalities by toxicity grade(End of treatment plus 7 days)
- Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)](Follow-up Week 24)
研究者
研究点 (1)
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