CTRI/2022/09/045934招募中Unknown
An observational, 24 week, open-label, multi-center,prospective post marketing surveillance study to evaluate thesafety, tolerability and patient treatment experience (PTE) ofmepolizumab administration via autoinjector for adult patientsaged 18 years or older suffering with severe eosinophilicasthma.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- of special interest (AESI)
研究概览
简要总结
The primary purpose of this post marketing, observational, prospective, real world study is the safety and tolerability of the subcutaneous administration of mepolizumab liquid drug product available as a ready to use prefilled autoinjector pen for patients 18 years or older, diagnosed with severe eosinophilic asthma.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from severe refractory eosinophilic asthma who have an indication from prescribing physician to start or have already started an add on treatment of mepolizumab by SC administration by patients or caregivers at home or healthcare providers in-clinic using a ready to use prefilled autoinjector.
排除标准
- •Patients with other conditions that could lead to elevated eosinophils such as Hyper eosinophilic Syndromes including Churg-Strauss Syndrome or Eosinophilic Esophagitis Patients with a known pre existing parasitic infestation within 6 months prior to Visit 1 should be treated appropriately before inclusion in the study.
结局指标
主要结局
of special interest (AESI)
时间窗: 24 weeks
incidence of adverse events (AE),
时间窗: 24 weeks
serious adverse events (SAE) and adverse events
时间窗: 24 weeks
次要结局
- 1. Frequency and incidence of clinically(significant asthma exacerbations in the pre and)
研究者
研究点 (7)
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