Safety, Efficacy and Pharmacokinetics of BI 201335 NA in Patient With Genotype 1 Chronic Hepatitis C Virus Infection in Combination With Pegylated Interferon Alfa-2b and Ribavirin - Cohort 1 for Treatment-naive Patients: Randomised, Double-blind Part of BI 201335 NA for 12 or 24 Weeks - Cohort 2 for Treatment-experienced Patients: Open-label Part of BI 201335 NA for 24 Weeks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 24
- 主要终点
- Number of Patients With Investigator Defined Drug-related Adverse Events
研究概览
简要总结
The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients
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
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1. BI 201335 low dose plus PegIFN/RBV
low dose BI 201335 NA once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
干预措施: BI 201335 low dose (Drug)
2. BI 201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 12 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
干预措施: BI 201335 high dose (Drug)
3. BI 201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients
干预措施: BI 201335 high dose (Drug)
4. BI 201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 48 weeks in treatment-experienced (null responder, partial responder, breakthrough) patients
干预措施: BI 201335 high dose (Drug)
结局指标
主要结局
Number of Patients With Investigator Defined Drug-related Adverse Events
时间窗: Up to 52 weeks
Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
次要结局
- Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)(EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72))
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES(12 weeks after the EOT (up to Week 36 or 60))
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES(EOT (up to Week 24 or 48))
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES(12 weeks after the EOT (up to Week 36 or 60))
- Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)(EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60))
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES(EOT (up to Week 24 or 48))
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO(EOT (up to Week 24 or 48))
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO(12 weeks after the EOT (up to Week 36 or 60))
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO(12 weeks after the EOT (up to Week 36 or 60))
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO(EOT (up to Week 24 or 48))
- Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8(up to 8 weeks)