NCT01979939已完成3 期
A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C
Bristol-Myers Squibb44 个研究点 分布在 3 个国家目标入组 416 人开始时间: 2013年12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
- 416
- 试验地点
- 44
- 主要终点
- Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12
研究概览
简要总结
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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 ≥ 10,000 IU/mL at screening
- •Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
- •Treatment-experienced subjects are eligible
排除标准
- •Evidence of cirrhosis
- •Liver or any other organ transplant
- •Current or known history of cancer within 5 years prior to enrollment
- •Documented or suspected HCC
- •Evidence of decompensated liver
研究组 & 干预措施
A 1: DCV/ASV/BMS-791325 in treatment-naive subjects
Experimental
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks
干预措施: DCV/ASV/BMS-791325 (Drug)
A 2: DCV/ASV/BMS-791325 in treatment-experienced subjects
Experimental
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks
干预措施: DCV/ASV/BMS-791325 (Drug)
结局指标
主要结局
Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12
时间窗: Post-Treatment Week 12
SVR12 is defined as HCV ribonucleic acid (RNA) \< limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12
次要结局
- Proportion of subjects in the experienced cohort with SVR12(Follow up Week 12)
- Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND(On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24))
- Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND(On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24)
- Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort(Up to post treatment week 4 (±7 days))
- Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort(Up to post treatment week 4 (±7 days))
- Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort(Up to post treatment week 4 (±7 days))
- Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b(Post treatment week 12)
- Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype)(Post treatment week 12)
- Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis(Post treatment week 12)
研究者
研究点 (44)
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