Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 71
- 主要终点
- Sustained Virological Response (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 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV
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
- 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
BI 201335 24 W
patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks
干预措施: PegIFN/RBV (Drug)
BI 201335 24W
patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks
干预措施: PegIFN/RBV (Drug)
BI201335 12W
patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks
干预措施: PegIFN/RBV (Drug)
BI201335 12W
patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks
干预措施: BI201335 (Drug)
BI 201335 24W
patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks
干预措施: BI201335 24W (Drug)
BI 201335 24 W
patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks
干预措施: Bi 201335 (Drug)
结局指标
主要结局
Sustained Virological Response (SVR12)
时间窗: 60 weeks
Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level \<25 IU/mL, undetected 12 weeks after the planned end of treatment.
次要结局
- Virological Response 24 Weeks Post Treatment (SVR24)(72 weeks)
- Early Treatment Success (ETS)(Week 4, week 8 and week 60)
- The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes(48 weeks)
- The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no(48 weeks)
- The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes(60 weeks)
- The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no(60 weeks)
- The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes(48 weeks)
- The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no(48 weeks)
- The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes(60 weeks)
- The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no(60 weeks)