A Real-World Study to Determine Patient Characteristics, Treatment Patterns, Clinical and Patient-Reported Outcomes of Patients With Hereditary Angioedema That Self-Administered Icatibant Using Homecare Services in the UK
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Number of Participants Treated with Icatibant in the Homecare Setting who Were Receiving Prophylaxis Treatment at Index
研究概览
简要总结
The main aim of this study is to describe the treatment patterns, characteristics and outcomes of people with HAE who are currently receiving icatibant in the homecare setting in the United Kingdom (UK).
Participants will be treated with icatibant according to their routine practice via homecare service for icatibant within the UK. Data will be directly collected from participants via study diaries and questionnaires. Participants will be contacted approximately every 90 days during study duration (this can occur via phone or as a face-to-face visit).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants Treated with Icatibant in the Homecare Setting who Were Receiving Prophylaxis Treatment at Index
时间窗: Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
Number of Participants Treated with Icatibant in the Homecare Setting in Each Prophylactic Treatment Type
时间窗: Up to 12 months from Index (day of the first homecare telephonic consultation/visit)
次要结局
- Time from the Start of Each HAE Attack to Administration of Icatibant in the Homecare Setting(Up to 12 months from Index (day of the first homecare telephonic consultation/visit))
- Number of Participants by Treatment Patterns(Up to 12 months from Index (day of the first homecare telephonic consultation/visit))
- Number of Participants Categorized by Their Clinical Characteristics(At Index (day of the first homecare telephonic consultation/visit))
- Frequency of Visits to Accident and Emergency Services Related to an HAE Attack(Up to 12 months from Index (day of the first homecare telephonic consultation/visit))
- AE-QoL Total Score(Up to 12 months from Index (day of the first homecare telephonic consultation/visit))
- Number of Participants Categorized by Their Demographic Characteristics(Baseline Period [3 months prior to Index (day of the first homecare telephonic consultation/visit)])
- Number of Participants by Treatment Management Patterns(Up to 12 months from Index (day of the first homecare telephonic consultation/visit))
- EQ-5D-5L Score(Up to 12 months from Index (day of the first homecare telephonic consultation/visit))
- Rate of New HAE Attacks(Up to 12 months from Index (day of the first homecare telephonic consultation/visit))
- Frequency of Icatibant Administration Following Start of Each HAE Attack(Up to 12 months from Index (day of the first homecare telephonic consultation/visit))
- Angioedema Control Test (AECT) Total Score(Up to 12 months from Index (day of the first homecare telephonic consultation/visit))