NCT03240991已完成不适用
Study of Clinical, Biological Characteristics and Quality of Life of Patients With Hereditary or Acquired Non Drug-induced Bradykinin-mediated Angioedema, Monitored in Besançon's Partner Site Reference Center for Studies of Kinin-mediated Angioedema (CREAK)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Dermatology Life Quality Index (DLQI)
研究概览
简要总结
This study aims to describe quality of life in hereditary or acquired non drug-related bradykinin-mediated angioedema patients, using validated questionnaires
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Clinically documented angioedema due to C1 inhibitor deficiency, hereditary (type I et II) or acquired
- •Clinically documented angioedema with normal C1 inhibitor activity (hereditary type III)
排除标准
- •Acquired angioedema with normal C1 inhibitor activity (former "drug-induced")
- •Minor subjects
- •Vulnerable subjects (under guardianship/curatorship/tutorship)
- •Pregnant women
结局指标
主要结局
Dermatology Life Quality Index (DLQI)
时间窗: 6 months
Description of Quality of Life (QoL) using DLQI
Angioedema Quality of Life (AE-QoL) Questionnaire
时间窗: 6 months
Description of QoL using AE-QOL questionnnaire
次要结局
未报告次要终点
研究者
研究点 (1)
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