NCT05729711进行中（未招募）不适用
TEZSPIRE Subcutaneous Injection 210mg Specific Use-results Study (Long Term) in Patients With Bronchial Asthma.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 416
- 试验地点
- 34
- 主要终点
- Incidence of ADRs
研究概览
简要总结
The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire.
- Development of related AEs
- Contributing factors possibly having an impact on the safety and effectiveness
- Development of unexpected related AEs
详细描述
The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire.
- Development of related AEs
- Contributing factors possibly having an impact on the safety and effectiveness
- Development of unexpected related AEs
This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Act on Securing Quality, Effectiveness and Safety of Products Including Pharmaceuticals and Medical Devices.
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
- •The evaluable patients are those treated with Tezspire for the first time due to "Bronchial asthma (only the patients with severe or intractable bronchial asthma which could not be controlled with the existing therapy)
排除标准
- 未提供
结局指标
主要结局
Incidence of ADRs
时间窗: 156 weeks
the incidence of ADRs related to Tezspire Safety Specifications: Serious hypersensitivity, infection, malignancy, cardiac disorders
次要结局
未报告次要终点
研究者
研究点 (34)
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