A Phase 3, Comparative Study of Asunaprevir and Daclatasvir (DUAL) Combination Therapy Versus Telaprevir Therapy in Japanese Genotype 1b Chronic Hepatitis C IFN Eligible-naive Subjects With a Single Arm Assessment of DUAL Therapy in IFN-therapy Relapsers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort
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 subject.
The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese Hepatitis C virus (HCV) subjects
详细描述
Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort
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
- 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 Ribonucleic acid (RNA) > 100,000 IU/mL at screening
- •Ages 20 to 70 years (for the Naive cohort), ages 20 to 75 years (for the Relapser cohort)
- •Treatment naive subjects to Interferon (IFN) based therapy
- •Subjects who had undetectable HCV RNA at end of treatment with prior exposure to an IFN-containing regimen, but HCV RNA detectable within 24 weeks of treatment follow-up
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
Arm 3: Daclatasvir + Asunaprevir
Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks
- Relapser cohort
干预措施: Asunaprevir (Drug)
Arm 1: Daclatasvir + Asunaprevir
Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks
- Naive cohort
干预措施: Daclatasvir (Drug)
Arm 1: Daclatasvir + Asunaprevir
Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks
- Naive cohort
干预措施: Asunaprevir (Drug)
Arm 2: Telaprevir + pegIFNα-2b + Ribavirin
Telaprevir 750 mg tablets by mouth three times daily, pegIFNα-2b 1.5 μg/kg solution by Subcutaneous weekly & Ribavirin 600- 1000 mg Capsules by mouth twice daily for 24 Weeks
- Naive cohort
干预措施: Ribavirin (Drug)
Arm 2: Telaprevir + pegIFNα-2b + Ribavirin
Telaprevir 750 mg tablets by mouth three times daily, pegIFNα-2b 1.5 μg/kg solution by Subcutaneous weekly & Ribavirin 600- 1000 mg Capsules by mouth twice daily for 24 Weeks
- Naive cohort
干预措施: pegIFNα-2b (Biological)
Arm 2: Telaprevir + pegIFNα-2b + Ribavirin
Telaprevir 750 mg tablets by mouth three times daily, pegIFNα-2b 1.5 μg/kg solution by Subcutaneous weekly & Ribavirin 600- 1000 mg Capsules by mouth twice daily for 24 Weeks
- Naive cohort
干预措施: Telaprevir (Drug)
Arm 3: Daclatasvir + Asunaprevir
Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks
- Relapser cohort
干预措施: Daclatasvir (Drug)
结局指标
主要结局
Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort
时间窗: After 12 weeks of the last dose
* SVR12 = Sustained virologic response at post-treatment Week 12 * LLOQ = Lower Limit of quantitation
次要结局
- Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort(At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and post-treatment Week 24)
- Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort(At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and Week 24)
- Proportion of subjects with HCV RNA target not detected in the relapser cohort(At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24)
- On treatment safety, as measured by the frequency of Severe adverse events (SAEs), discontinuation and dose modification/interruption due to Adverse events (AEs), Grade 3-4 abnormalities observed from clinical laboratory tests for each treatment group(End of treatment (24 weeks) plus 7days)
- Proportion of subjects with hemoglobin < 10g/dL(First 12 weeks of treatment)
- Proportion of subjects with rash-related dermatologic events(First 12 weeks of treatment)
- Proportion of subjects with HCV RNA target not detected in the naive cohort(At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24)
- Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort(At post-treatment Week 12)