A Phase IIb Open Label Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Patients With Moderate Hepatic Impairment (Child-Pugh B) With Genotype 1b Chronic Hepatitis C Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 19
- 主要终点
- SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)
研究概览
简要总结
To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).
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
- 18 Years 至 75 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
cohort A CPA
Cohort A CPA BI 207127/QD Faldaprevir Ribavirin
干预措施: Ribavirin (Drug)
cohort A CPA
Cohort A CPA BI 207127/QD Faldaprevir Ribavirin
干预措施: Faldaprevir (Drug)
cohort A CPA
Cohort A CPA BI 207127/QD Faldaprevir Ribavirin
干预措施: BI 207127 low dose (Drug)
cohort A CPB
Cohort B CPB BI 207127/QD Faldaprevir Ribavirin
干预措施: BI 207127 high dose (Drug)
cohort A CPB
Cohort B CPB BI 207127/QD Faldaprevir Ribavirin
干预措施: Ribavirin (Drug)
cohort A CPB
Cohort B CPB BI 207127/QD Faldaprevir Ribavirin
干预措施: Faldaprevir (Drug)
结局指标
主要结局
SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)
时间窗: 12 weeks after End of Treatment
Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.
次要结局
- SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)(4 weeks after End of Treatment)