NCT03845400已完成不适用
An Observational, Non-interventional, Study of Patients With Hereditary Angioedema in the United States and Canada (EMPOWER Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 168
- 试验地点
- 29
- 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 before and after lanadelumab treatment was started in persons with Hereditary Angioedeme Type I or II.
Data from participants will be collected for at least 24 months. Participants will report information in a smartphone application at study start and then every 3 months until the study ends; data will also be collected by the study doctor during routine clinic visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily provide written, signed, and dated (personally or via a legally-authorized representative) informed consent/and assent as applicable to participate in the study. Expression of understanding and agreement by fully informed parent(s) or legal guardian is required to permit the investigator to enroll a child in this study. The choice of the terms parental consent or parental permission in different regions may reflect local legal/regulatory and ethical considerations.
- •Diagnosis of HAE Type I or Type II.
- •Ability to use a mobile device for data collection in the study.
排除标准
- •Participation in any interventional clinical trial at the time of enrollment.
- •Unable to provide written, signed, and dated informed consent/assent.
- •Investigator believes that the participant is not a suitable candidate for the study.
结局指标
主要结局
Number of Hereditary Angioedema (HAE) Attacks
时间窗: From enrollment up to 36 months
Number of HAE attacks before and after lanadelumab initiation will be reported.
次要结局
- Time From Diagnosis to Lanadelumab Initiation(From enrollment up to 36 months)
- Number of Hospitalizations due to Hereditary Angioedema (HAE) Attack(s)(From enrollment up to 36 months)
- Rescue Medications Taken at Time of Hereditary Angioedema (HAE) Attack(s)(From enrollment up to 36 months)
- Dose of Lanadelumab Injections(From enrollment up to 36 months)
- Frequency of Lanadelumab Injections(From enrollment up to 36 months)
- Number of Lanadelumab Injections Before Discontinuation per Reason for Injection(From enrollment up to 36 months)
- Number of Emergency Room (ER) Visits due to Hereditary Angioedema (HAE) Attack(s)(From enrollment up to 36 months)
- Angioedema Quality of Life (AE-QoL) Score(From enrollment up to 36 months (every 3 months))
- Work Productivity and Activity Impairment: General Health (WPAI:GH) Score(From enrollment up to 36 months (every 3 months))
- Proportion of Participants who Discontinue Lanadelumab(From enrollment up to 36 months)
- Treatment Satisfaction (TSQM-9) Score(From enrollment up to 36 months (every 3 months))
- Proportion of Injections Based on the Type of Administration of Lanadelumab(From enrollment up to 36 months)
- Number of Physician Visits due to Hereditary Angioedema (HAE) Attack(s)(From enrollment up to 36 months)
- Hereditary Angioedema (HAE) Attack Control Score Before and After Lanadelumab Initiation, as Measured by the Angioedema Control Test (AECT)(From enrollment up to 36 months (every 3 months))
研究者
研究点 (29)
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