Antiviral Effect and Safety of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naive Patients for 12 or 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Randomised, Open Label, Phase II)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 28
- 主要终点
- Virological Response at Week 28 (W28VR)
研究概览
简要总结
To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1
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
short arm
patients to receive BI201335 with PegIFN/RBV for 12 wks followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV)
干预措施: BI 201335 (Drug)
short arm
patients to receive BI201335 with PegIFN/RBV for 12 wks followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV)
干预措施: Pegylated Interferon-alpha (IFN) (Drug)
short arm
patients to receive BI201335 with PegIFN/RBV for 12 wks followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV)
干预措施: Ribavirin (RBV) (Drug)
long arm
patients to receive BI201335 with PegIFN/RBV for 24 wks with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV)
干预措施: BI 201335 (Drug)
long arm
patients to receive BI201335 with PegIFN/RBV for 24 wks with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV)
干预措施: Pegylated Interferon-alpha (IFN) (Drug)
long arm
patients to receive BI201335 with PegIFN/RBV for 24 wks with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV)
干预措施: Ribavirin (RBV) (Drug)
结局指标
主要结局
Virological Response at Week 28 (W28VR)
时间窗: 28 weeks
Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.
次要结局
- Rapid Virological Response at Week 4 (RVR)(4 weeks)
- Virological Response at Week 24 (W24VR)(24 weeks)
- Virological Response at Week 36 (W36VR)(36 weeks)
- End of Treatment Response (ETR)(up to 48 weeks)
- Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy(72 weeks)
- Viral Load (HCV RNA) at All Visits During Treatment and Follow-up(From baseline to 72 weeks)
- Time to Reach a Plasma HCV RNA Level BLD While on Treatment(48 weeks)
- Laboratory Test Abnormalities and Study Medication Tolerabilities(48 weeks)
- Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination(48 weeks)
- Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)(baseline and 48 weeks)
- Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)(baseline and 48 weeks)
- Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)(baseline and 48 weeks)
- Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)(baseline and 48 weeks)
- Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)(baseline and 48 weeks)
- Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)(baseline and 48 weeks)