EUCTR2011-002339-24-GB进行中（未招募）1 期
Open label, single-centre study to evaluate the efficacy of the bradykinin (BK) B2 receptor antagonist, Icatibant, in the relief of symptoms resulting from moderate to severe angioedema unresponsive to antihistamines - Study of Icatibant in Idiopathic Angioedema
Barts and the London NHS Trust0 个研究点目标入组 9 人开始时间: 2012年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9
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; • Age = than 18 years; • C1-inhibitor functional levels = 50% of normal values • Current oedema attack must be in the cutaneous or mucosal areas; • Current oedema attack must be moderate to severe; • Women of childbearing potential must have a negative urine pregnancy test; • Signed written Informed Consent given
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Diagnosis of angioedema of any defined cause, for example, allergic, hereditary/acquired C1-Inhibitor deficiency, ACE inhibitor induced angioedema, drug and/or food induced angioedema; • Urticaria-associated angioedema • Participation in a clinical trial of another Investigational Product (IP) within the past month; • Treatment with any other medication likely to influence the outcome since onset of the current oedema attack; • On treatment with ACE inhibitors; • Evidence of severe coronary artery disease based on medical history or screening examination; • Pregnancy and/or breast-feeding; • Mental or physical condition rendering the subject, in the opinion of the investigator, unable to understand the nature, scope and possible consequences of the study; • Unlikely to comply with the protocol
研究者
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