Demographic and Clinical Characteristics, Treatment Patterns, and Real-world Effectiveness of Lanadelumab in Patients With Hereditary Angioedema Type I or II in the United Kingdom: an Ambispective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Hereditary Angioedema (HAE) Attacks
研究概览
简要总结
The main aim of this study is to compare the HAE attack rate requiring on-demand treatment before and within 2 years after participants with HAE have been treated with lanadelumab.
This study is conducted in the United Kingdom where participants were treated or about to be treated with landelumab according to their routine practice at hospitals. Data will be directly collected from participants via study diaries, questionnaires, their medical records, and study doctors treating them. Participants will be contacted every 3 months during study participation (via phone).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 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 Hereditary Angioedema (HAE) Attacks
时间窗: Up to approximately 3 years
Number of HAE attacks (both total \[including untreated\] and those requiring on-demand treatment) will be estimated across the pre- and post-treatment periods (that is, 12 months before and up to 24 months after initiation of treatment with lanadelumab).
次要结局
- Number of Participants Categorized by Their Demographic Characteristics(At index (lanadelumab treatment initiation day))
- Number of Participants Categorized by Their Clinical Characteristics(Up to approximately 3 years)
- Number of Participants Categorized by Their Treatment Patterns(At and after index (lanadelumab treatment initiation day plus approximately 2 years))
- Number of Participants Categorized by Their Patterns of Prophylactic Treatment(Up to approximately 3 years)
- Compare the Number of Participants Categorized by Their Clinical Features of HAE Attacks Before and After Initiation of Lanadelumab(Up to approximately 3 years)
- Number of Self-Reported HAE Attacks(Up to approximately 3 years)
- Number of Participants Categorized by Their Clinical Features of Self-Reported HAE Attacks(Up to approximately 3 years)
- European Quality of Life 5 Dimensions 3-levels (EQ-5D-3L) Questionnaire Total Score(Up to approximately 2 years)
- EQ-5D-3L Visual Analogue Scale (VAS) Score(Up to approximately 2 years)
- Angioedema Quality of Life (AE-QoL) Total Scores(Up to approximately 2 years)
- Angioedema Quality of Life (AE-QoL) Domain Scores(Up to approximately 2 years)
- Number of Participants With HAE-related Health Care Resource Utilization (HCRU)(Up to approximately 3 years)
- Angioedema Control Test (AECT) Total Score(Up to approximately 2 years)
- Angioedema Control Test (AECT) Domain Score(Up to approximately 2 years)
- Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score(Up to approximately 2 years)
- Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Score(Up to approximately 2 years)