A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 120 mg for 12 or 24 Weeks or BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 656
- 试验地点
- 98
- 主要终点
- Sustained Virological Response 12 Weeks Post-treatment (SVR12)
研究概览
简要总结
The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.
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
- 18 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
PegIFN/RBV
PegIFN/RBV for 48 weeks
干预措施: PegIFN/RBV (Drug)
BI 201335 for 12 or 24 weeks
BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks
干预措施: PegIFN/RBV (Drug)
BI 201335 for 12 or 24 weeks
BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks
干预措施: BI 201335 (Drug)
Placebo and PegIFN/RBV
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
干预措施: PegIFN/RBV (Drug)
Placebo and PegIFN/RBV
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
干预措施: Placebo (Drug)
结局指标
主要结局
Sustained Virological Response 12 Weeks Post-treatment (SVR12)
时间窗: 12 weeks post treatment, up to 60 weeks
Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level \< 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
次要结局
- Early Treatment Success (ETS)(week 4 and week 8)
- Sustained Virological Response 24 Weeks Post-treatment (SVR24)(24 weeks post treatment, up to 72 weeks)
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO(12 weeks post treatment, up to 60 weeks)
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO(12 weeks post treatment, up to 60 weeks)
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO(12 weeks post treatment, up to 60 weeks)
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO(12 weeks post treatment, up to 60 weeks)