Specific Use-Results Survey of TAKHZYRO Subcutaneous Injection 300 mg Syringe for Hereditary Angioedema With Long-term Administration
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)
研究概览
简要总结
This study is a survey in Japan of Lanadelumab used to treat people with hereditary angioedema (HAE). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects related from Lanadelumab and to check if Lanadelumab improves symptoms of HAE. During the study, participants with HAE will take Lanadelumab subcutaneous injection according to their clinic's standard practice. The study doctors will check for side effects from Lanadelumab for 12 months.
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
- •Participants diagnosed with hereditary angioedema (HAE) and treated with Lanadelumab for the first time.
排除标准
- 未提供
研究组 & 干预措施
Lanadelumab
Participants will receive 300 milligram (mg) of Lanadelumab Subcutaneous (SC) injection once every 2 weeks.
干预措施: Lanadelumab (Drug)
结局指标
主要结局
Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)
时间窗: 12 Months
An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product. An adverse event does not necessarily have a causal relationship with the intervention. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
次要结局
- Number of Angioedema Attacks(12 Months)
- Angioedema Quality of life (AE-QoL) Questionnaire(12 Months)