NCT01825980已完成1 期
Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Determine the Safety and Antiviral Effect of 3 Days of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus (HCV) Infected Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- HCV viral load
研究概览
简要总结
To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any assessment is performed Male & female treatment naive subjects, age 18-60 years of age with Hepatitis C genotype-
- •Subjects must weight at least 50kg to participate in the study, and must have a body mass index (BMI) within the range of 18-36 kg/m2 Able to communicate well with the investigator, to understand and comply with the study requirements.
排除标准
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer: or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- •Subjects that were previously treated for HCV infection.
研究组 & 干预措施
BZF961
Experimental
干预措施: Ritonavir (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
BZF961
Experimental
干预措施: BZF961 (Drug)
结局指标
主要结局
HCV viral load
时间窗: Day 3
Viral load samples will be taken at Day 3.
次要结局
- Number of participants with adverse events as a measure of safety(2 weeks)
- Total BZF961 concentration in plasma(Day 4)
研究者
研究点 (1)
Loading locations...
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