A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 678
- 试验地点
- 116
- 主要终点
- Sustained Virological Response 12 Weeks Post Treatment (SVR12)
研究概览
简要总结
The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.
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 (Participant, Investigator)
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
Placebo/PegIFN/RBV
patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
干预措施: Pegylated Interferon-alpha (IFN) (Drug)
Placebo/PegIFN/RBV
patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
干预措施: Ribavirin (RBV) (Drug)
Placebo/PegIFN/RBV
patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
干预措施: Placebo (Drug)
BI201335 12 weeks
patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks
干预措施: BI 201335 (Drug)
BI201335 12 weeks
patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks
干预措施: Pegylated Interferon-alpha (IFN) (Drug)
BI201335 12 weeks
patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks
干预措施: Ribavirin (RBV) (Drug)
BI201335 24 weeks
patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
干预措施: BI 201335 (Drug)
BI201335 24 weeks
patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
干预措施: Pegylated Interferon-alpha (IFN) (Drug)
BI201335 24 weeks
patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
干预措施: Ribavirin (RBV) (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
Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
次要结局
- Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)(24 weeks post treatment, up to 72 weeks)
- AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO(12 weeks post treatment, up to 60 weeks)
- AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO(End of treatment, up to 48 weeks)
- AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES(End of treatment, up to 48 weeks)
- ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES(12 weeks post treatment, up to 60 weeks)
- Early Treatment Success (ETS)(Week 4 and Week 8)
- AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES(12 weeks post treatment, up to 60 weeks)
- ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO(End of treatment, up to 48 weeks)
- ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES(End of treatment, up to 48 weeks)
- ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO(12 weeks post treatment, up to 60 weeks)