EUCTR2012-001670-28-DE进行中（未招募）1 期
Angiotensin Converting Enzyme Inhibitor (ACE) Induced AngioedemaBERINERTRandomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema - BERINERT
Medizinische Fakultät der Technischen Universität München0 个研究点目标入组 52 人开始时间: 2012年8月14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
- 52
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
- •?Written informed consent to participate in the study and ability to fulfil all study requirements
- •?Male or female patients aged ?18 years
- •?Patients with ACE induced angioedema (grade II-III in at least one severity scale) with imminent airway obstruction admitted to an Emergency department
- •?Patient is being treated with ACEi
- •?Patient must have acute angioedema attack caused by ACEi
- •?Treatment should be administered within 10 hours after onset of the angioedema
- •?Patients with angioedema of the head and/or neck (face, lips, cheeks, tongue, soft palate/uvula, pharynx and larynx)
- •?Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country
- •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 52
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?Diagnosis of angioedema of other genesis: e.g. hereditary angioedema, C1-inhibitor deficiency, allergic oedema, anaphylaxis, insect bite, trauma, abscess, local inflammation,
- •?local tumour, post-operative or post-radiogenic oedema, salivary gland disorders
- •?Participation in a clinical study in the past 30 days
- •?Patients with simultaneous itchiness of skin (acute urticaria)
- •?Patients with a history of angioedema before taking ACEI
- •?History of hypersensitivity to any of the study drugs or medicine with a similar chemical structure.
- •?Pregnancy and/or breastfeeding
- •?Mental retardation of the patient with restriction of general judgment and awareness
- •?History of drug abuse (including alcohol and alcoholic liver disorders)
- •?Potentially unreliable patients
- •?Patients who are not suitable for the study in the opinion of the investigator
研究者
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