EUCTR2018-000605-24-DE进行中（未招募）1 期
A multicenter, randomized, placebo-controlled, parallel-arm study toinvestigate the efficacy, pharmacokinetics, and safety of CSL312 insubjects with hereditary angioedema
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female
- •- Aged = 18 to = 65 years
- •- A diagnosis of C1-INH HAE or FXII/PLG HAE;
- •- For subjects with C1-INH HAE: = 4 HAE attacks over a consecutive 2-
- •month period during the 3 months before Screening, as documented in
- •the subject's medical record.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- History of clinically significant arterial or venous thrombosis, or current
- •clinically significant prothrombotic risk
- •- History of an uncontrolled, abnormal bleeding event due to a
- •coagulopathy, or a current clinically significant coagulopathy or clinically
- •significant risks for bleeding events
- •- Known incurable malignancies
研究者
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