Safety, Pharmacokinetics and Antiviral Effect of BI 201335 NA in HCV-1 Infected Patients Treated for 28 Days for Treatment naïve and Experienced Patients Treated in Combination With Peg Interferon Alfa-2a and Ribavirin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy
研究概览
简要总结
The current Standard of Care (SOC) for chronic HCV infection, which is pegylated interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is effective in only part of the patients and is often associated with severe adverse effects leading to discontinuation of treatment and dose modifications.
A number of compounds with direct activity are currently under clinical development, incl. BI 201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN and RBV in HCV infected patients
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
- 20 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 NA low TN
patient to receive a capsule containing low dose of BI 201335 NA/Drug for treatment-naive (TN) patients
干预措施: pegylated interferon (PegIFN) alfa-2a (Drug)
BI 201335 NA low TN
patient to receive a capsule containing low dose of BI 201335 NA/Drug for treatment-naive (TN) patients
干预措施: BI 201335 NA low placebo (Drug)
BI 201335 NA low TN
patient to receive a capsule containing low dose of BI 201335 NA/Drug for treatment-naive (TN) patients
干预措施: ribavirin (RBV) (Drug)
BI 201335 NA low TN
patient to receive a capsule containing low dose of BI 201335 NA/Drug for treatment-naive (TN) patients
干预措施: BI 201335 NA low (Drug)
BI 201335 NA high TN
patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-naive (TN )patients
干预措施: ribavirin (RBV) (Drug)
BI 201335 NA high TN
patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-naive (TN )patients
干预措施: pegylated interferon (PegIFN) alfa-2a (Drug)
BI 201335 NA high TN
patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-naive (TN )patients
干预措施: BI 201335 NA high (Drug)
BI 201335 NA high TN
patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-naive (TN )patients
干预措施: BI 201335 NA high placebo (Drug)
BI 201335 NA high TE
patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-experienced (TE) patients
干预措施: pegylated interferon (PegIFN) alfa-2a (Drug)
BI 201335 NA high TE
patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-experienced (TE) patients
干预措施: ribavirin (RBV) (Drug)
BI 201335 NA high TE
patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-experienced (TE) patients
干预措施: BI 201335 NA high (Drug)
Placebo in Treatment Naive (TN) Patients
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy
时间窗: 4 weeks
Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
时间窗: 4 weeks
Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in triple combination therapy for treatment naive patients and treatment experienced patients.
Assessment of Tolerability in Triple Combination Therapy
时间窗: 4 weeks
An assessment of tolerability for the safety of the triple combination therapy with BI 201335 NA, PegIFN α -2a and RBV.
次要结局
- Early Virological Response (EVR)(12 Weeks)
- Complete Early Virological Response (cEVR)(12 weeks)
- Week 2 Virological Response (W2VR)(2 weeks)
- Week 4 Virological Response (W4VR)(4 weeks)
- Rapid Virological Response (RVR)(4 weeks)
- Change From Baseline in HCV Viral Load(baseline and week 4)
- Day 28 Virologic Response(4 weeks)
- End of Treatment Response (ETR)(48 weeks)
- Sustained Virologic Response (SVR)(72 weeks)
- Number of Participants With Investigator Defined Drug-related Adverse Events in Standard of Care (SOC) With PegIFN α-2a and RBV(44 weeks)
- Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV(44 weeks)
- Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV(44 weeks)
- AUCτ,1 for BI 201335 ZW(10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose)
- Cmax of BI 201335 ZW(10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose)
- AUCτ,ss of BI 201335 ZW(10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose)
- Cmax,ss of BI 201335 ZW(10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose)
- AUCτ,1 for Ribavirin (RBV)(-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose)
- Tmax, ss for BI 201335 ZW(10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose)
- Cmax of RBV(-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose)
- AUCτ,ss of RBV(-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose)
- Cmax,ss of RBV(-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose)
- Tmax for BI 201335 ZW(10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose)
- Tmax for RBV(10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose)
- Tmax, ss for RBV(10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose)
- t1/2,ss for BI 201335 ZW(10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose)
- Cmin,ss for BI 201335 ZW(10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose)
- Cmin,ss for RBV(10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose)
- Cavg for BI 201335 ZW(10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose)
- Cavg for RBV(10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose)
- CL/F,ss for BI 201335 ZW(10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose)