NCT01984788已完成2 期
A Phase 2a Double-Blind Placebo-Controlled 2-Period Crossover Study to Evaluate the Safety and Efficacy of BCX4161 as a Prophylactic Treatment to Reduce the Frequency of Attacks in Subjects With Hereditary Angioedema
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
- 24
- 试验地点
- 6
- 主要终点
- Number of acute angioedema attacks
研究概览
简要总结
The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic treatment is safe and effective in reducing the number of acute attacks in patients with hereditary angioedema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Clinical and laboratory diagnosis of Hereditary Angioedema Type I or II
- •An average angioedema attack frequency of 1/week
- •Acceptable birth control measures
排除标准
- •Concurrent use of defined treatments for prophylaxis
- •Pregnancy or breast-feeding
- •Clinically significant medical condition, laboratory abnormality or medical history
研究组 & 干预措施
BCX4161
Active Comparator
400 mg TID for 28 days
干预措施: BCX4161 (Drug)
Placebo
Placebo Comparator
TID for 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of acute angioedema attacks
时间窗: Over 28 days of treatment
次要结局
- Number of attack free days(Over 28 days of treatment)
- Incidence and severity of adverse events and laboratory abnormalities(Over 28 days of treatment)
- Angioedema activity scores(Over 28 days of treatment)
- Angioedema Quality of Life scores(Over 28 days of treatment)
研究者
研究点 (6)
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