DRKS00010438已完成3 期
HELP Study (TM): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate DX-2930 For Long-Term Prophylaxis Against Acute Attacks of Hereditary Angioedema (HAE) - HELP
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Dyax Corp.
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Documented diagnosis of HAE, Type I or II
- •- Baseline rate of at least 1 Investigator-confirmed HAE attack per 4 weeks
- •- Executed informed consent
排除标准
- •–Concomitant diagnosis of another form of chronic, recurrent angioedema, such as acquired angioedema
- •–Treatment with any other investigational drug or exposure to an investigational device within 4 weeks prior screening
- •–Exposure to ACE inhibitors or any estrogen-containing medications within 4 weeks prior to screening.
- •–Exposure to androgens or long-term prophylactic therapy for HAE within 2 weeks prior to entering the run-in period.
- •–Use of short-term prophylaxis for HAE within 7 days prior to entering the run-in period.
- •–Pregnancy or breastfeeding.
研究者
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