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临床试验/NCT01528735
NCT01528735已完成2 期

An Open-label, Ascending Dose, Phase II Study to Evaluate Tolerability, Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA in Combination With BI 201335 NA and Ribavirin for 8 Weeks in Treatment-naïve Japanese Patients With Genotype 1chronic Hepatitis C Virus Infection

Boehringer Ingelheim5 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2012年2月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
25
试验地点
5
主要终点
Number of Patients With Drug-related Adverse Events
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this trial is to investigate tolerability, safety, pharmacokinetics and antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in Japanese treatment-naive patients with chronic GT-1 HCV infection.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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 207127 NA, BI 201335 NA(high dose), R

Experimental

Patients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

干预措施: peginterferon (Drug)

BI 207127 NA, BI 201335 NA(high dose), R

Experimental

Patients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

干预措施: Ribavirin (Drug)

BI 207127 NA, BI 201335 NA(high dose), R

Experimental

Patients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

干预措施: BI 207127 NA (Drug)

BI 207127 NA, BI 201335 NA(high dose), R

Experimental

Patients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

干预措施: BI 201335 NA (Drug)

BI 207127 NA,BI 201335 NA(low dose),RBV

Experimental

Patients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

干预措施: BI 207127 NA (Drug)

BI 207127 NA,BI 201335 NA(low dose),RBV

Experimental

Patients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

干预措施: Ribavirin (Drug)

BI 207127 NA,BI 201335 NA(low dose),RBV

Experimental

Patients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

干预措施: BI 201335 NA (Drug)

BI 207127 NA,BI 201335 NA(low dose),RBV

Experimental

Patients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

干预措施: peginterferon (Drug)

结局指标

主要结局

Number of Patients With Drug-related Adverse Events

时间窗: From first dose of study medication until 30 days after last dose of study medication, up to 199 days

Number of patients with investigator defined drug-related Adverse Events

次要结局

  • Percentage of Participants With Virological Response at Week 8(8 weeks)
  • Percentage of Participants With Virological Response at Week 4(4 weeks)
  • Maximum Measured Concentration (Cmax) of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Maximum Measured Concentration (Cmax) of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Maximum Measured Concentration (Cmax) of CD 6168(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57)
  • Time From Last Dosing to the Maximum Concentration (Tmax) of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Time From Last Dosing to the Maximum Concentration (Tmax) of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Maximum Measured Concentration (Cmax) of BI 208333(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168-AG(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Area Under the Curve (AUC) of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Time From Last Dosing to the Maximum Concentration (Tmax) of BI 208333(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Area Under the Curve (AUC) of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Area Under the Curve (AUC) of CD 6168(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Predose Measured Concentration of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57)
  • Cmax Accumulation Ratio (RA,Cmax,N) of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Area Under the Curve (AUC) of BI 208333(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Maximum Measured Concentration (Cmax) of CD 6168-AG(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57)
  • Area Under the Curve (AUC) of CD 6168-AG(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • AUC Accumulation Ratio of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Mean Residence Time (MRTpo,ss) of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57)
  • Maximum Measured Concentration (Cmax) of RBV(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57)
  • Time From Last Dosing to the Maximum Concentration (Tmax) of RBV(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57)
  • Area Under the Curve (AUC) of RBV(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57)
  • Cmax Accumulation Ratio (RA,Cmax,N) of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • AUC Accumulation Ratio of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Mean Residence Time (MRTpo,ss) of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57)
  • Apparent Clearance (CL/F,ss) of Deleobuvir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57)
  • Apparent Clearance (CL/F,ss) of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57)
  • Predose Measured Concentration of Faldaprevir(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57)
  • Cmax Accumulation Ratio of BI 208333(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • AUC Accumulation Ratio of BI 208333(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57)
  • Mean Residence Time (MRTpo,ss) of BI 208333(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57)
  • Predose Measured Concentration of BI 208333(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57)
  • Cmax Accumulation Ratio of CD 6168(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57)
  • AUC Accumulation Ratio of CD 6168(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57)
  • Mean Residence Time (MRTpo,ss) of CD 6168(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57)
  • Predose Measured Concentration of CD 6168(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57)
  • Cmax Accumulation Ratio of CD 6168-AG(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57)
  • AUC Accumulation Ratio of CD 6168-AG(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57)
  • Mean Residence Time (MRTpo,ss) of CD 6168-AG(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57)
  • Predose Measured Concentration of CD 6168-AG(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57)
  • AUC Accumulation Ratio of RBV(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57)
  • Cmax Accumulation Ratio (RA,Cmax,57) of RBV(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57)
  • Mean Residence Time (MRTpo,ss) of RBV(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on day 57)
  • Predose Measured Concentration of RBV(10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 11 and 57)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (5)

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