Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- time of resolution
研究概览
简要总结
This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema.
This study should show that Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment. This study should also compare the time to onset of relief as defined by an at least one point reduction on the severity scale of ACE-induced angioedema with Berinert versus placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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) 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
- •Signed patient information consent form
排除标准
- •Diagnosis of angioedema of other genesis: e.g. hereditary angioedema, C1-inhibitor deficiency, allergic edema, anaphylaxis, insect bite, trauma, abscess, local inflammation, local tumour, post-operative or post-radiogenic edema, 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
研究组 & 干预措施
Group 1
Cortisone, Clemastin + BERINERT
干预措施: Berinert (Drug)
Group 1
Cortisone, Clemastin + BERINERT
干预措施: Clemastin (Drug)
Group 1
Cortisone, Clemastin + BERINERT
干预措施: Cortisone acetate (Drug)
Group 2
Cortinsone, Clemastin + NaCl
干预措施: Clemastin (Drug)
Group 2
Cortinsone, Clemastin + NaCl
干预措施: Cortisone acetate (Drug)
Group 2
Cortinsone, Clemastin + NaCl
干预措施: NaCl (Drug)
结局指标
主要结局
time of resolution
时间窗: 07/2013 until 12/2014
Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment.
次要结局
未报告次要终点