A Phase III, Randomized, Double Blind and Placebo Controlled Study of Once Daily BI 201335 120 mg for 24 Weeks and BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon Alpha and Ribavirin in Treatment Naive 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
- 658
- 试验地点
- 106
- 主要终点
- Sustained Virologic 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
48 weeks
干预措施: PegIFN/RBV (Drug)
BI 201335 for 24 weeks
BI 201 335 QD dosing in combination with IFN/RBV
干预措施: PegIFN/RBV (Drug)
BI 201335 for 24 weeks
BI 201 335 QD dosing in combination with IFN/RBV
干预措施: BI201335 (Drug)
BI201335 for 12 weeks
BI 201335 QD doing in combination with PEFG IFN/RBV
干预措施: BI201335 (Drug)
BI201335 for 12 weeks
BI 201335 QD doing in combination with PEFG IFN/RBV
干预措施: PegIFN/RBV (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
时间窗: 12 weeks post treatment, up to 60 weeks
Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) 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
- ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO(12 weeks post treatment, up to 60 weeks)
- ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO(12 weeks post treatment, up to 60 weeks)
- Early Treatment Success (ETS)(Week 4 and week 8)
- Sustained Virologic Response 24 Weeks Post-treatment (SVR24)(24 weeks post treatment, up to 72 weeks)
- AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO(12 weeks post treatment, up to 60 weeks)
- AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO(12 weeks post treatment, up to 60 weeks)