Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Lanadelumab (Takhzyro®) in Patients Aged 12 Years and Older With Hereditary Angioedema (HAE) in Argentina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Serious and Non-serious Adverse Events (AEs)
研究概览
简要总结
The main aim of this study is to learn about the safety profile of lanadelumab in teenagers and adults with hereditary angioedema (HAE) in Argentina as part of routine routine practice.
This study is about collecting data only. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study. The study will collect data from the participant's medical records.
Participants do not need to visit their doctor in addition to their normal visits.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants (>=12 years) with investigator confirmed diagnosis of HAE.
- •Have received at least one dose of lanadelumab according to approved indications.
- •Signed the mandatory consent that has been agreed with national regulatory authorities (ANMAT) as applicable.
排除标准
- •Hypersensitivity to the active substance or to any of the excipients.
结局指标
主要结局
Percentage of Participants With Serious and Non-serious Adverse Events (AEs)
时间窗: Baseline up to end of study (up to 24 months)
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Serious AE is any untoward medical occurrence (whether considered to be related to study assigned treatment or not) that at any dose resulted in death, is life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or was an important medical event. AEs including both serious and non-serious adverse events will be reported.
Percentage of Participants With Adverse Events of Special Interest (AESIs)
时间窗: Baseline up to end of study (up to 24 months)
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Percentage of participants with AESIs such as hypersensitivity, immunogenicity, liver toxicity, and embryo-fetal toxicity will be reported.
次要结局
- Monthly Mean Rate of Investigator Confirmed HAE Attacks Requiring Acute Treatment(At Weeks 12 and 24)
- Monthly Mean Rate of Investigator Confirmed HAE Attacks(At Weeks 12 and 24)
- Monthly Mean Rate of Investigator Confirmed Moderate or Severe HAE Attacks(At Weeks 12 and 24)
- Percentage of Participants who are Attack Free(At Weeks 12 and 24)