EUCTR2012-005824-13-IT进行中（未招募）1 期
Pilot study on efficacy of bilastine in preventing angioedema symptoms in patients with angioedema of unknown etiology (idiopathic angioedema, IAE) - Light
Menarini International Operation Luxembourg SA0 个研究点目标入组 50 人开始时间: 2013年2月12日最近更新:
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
- 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
入选标准
- •1.Subjects must have given a written informed consent
- •2.Male or female;
- •3.Age = 18 years;
- •4.Diagnosis of chronic IAE (according to Kaplan-Greaves 2005 criteria)
- •5.Presence of = 4 days of moderate to severe cutaneous or mucosal symptoms of angioedema per 4 weeks, in the last 12 weeks or more
- •6.No angioedema symptoms when starting the treatment
- •7.C1-inhibitor functional levels = 60% of normal values
- •8.Able to complete screening and assessments
- •9.Women of childbearing potential must have a negative urine pregnancy test;
- •10.Willingness and ability to participate in the study.
- •11.No other experimental treatments.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Diagnosis of angioedema of any defined cause: allergic, hereditary/acquired C1-Inhibitor deficiency, ACE (Angiotensin Converting Enzyme) inhibitor or NSAID induced angioedema, drug and/or food/disease induced angioedema (according to Kaplan-Greaves 2005 criteria);
- •2.Participation in a clinical trial of another Investigational Product (IP) within the past month;
- •3.On treatment with ACE inhibitors or ARB (Angiotensin Receptor Blockers);
- •4.Evidence of clinically relevant cardiovascular disease or thrombophylic condition
- •5.History of autoimmune disorders, Hodgkin’s disease and any clinically significant condition (neurological, hepatic, renal or malignant diseases) that upon the judgment of the investigator contraindicates participation to the study;
- •6.Pregnancy and/or breast-feeding;
- •7.Mental condition rendering the subject, in the opinion of the investigator, unable to understand the nature, scope and possible consequences of the study;
- •8.Unlikely to comply with the protocol, for example, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study for any reason;
- •9.Known hypersensitivity to bilastine, its excipients, H1-antihistamines, benzimidazoles
- •10.Patient with concomitant drugs as systemic or topical corticosteroids within 4 weeks, astemizole within 6 weeks, ketotifen within 2 weeks, any other systemic antihistamine (including loratadine, desloratadine, ebastine, rupatadine, mizolastine, cetirizine or levocetirizine) within 3 days, anti-leukotrienes within 3 days, sodium cromoglycate or nedocromil within 2 weeks, and tricyclic antidepressants within 1 week of randomization and ace-inibhitors, sartan drugs, cinnarizine, with the exception of the case in which some of them have been used for the symptoms.
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