NCT02075008终止2 期
An Open-label, Multi-center, Extension Study to Evaluate the Long-term Safety of Subcutaneous 240mg QGE031 Given Every 4 Weeks for 52 Weeks in Allergic Asthma Patients Who Completed Study CQGE031B2201
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability
研究概览
简要总结
This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201.
详细描述
This study planned to assess long-term safety and tolerability of QGE031 administered every 4 weeks for an additional 12 months in patients with allergic asthma who previously completed study CQGE031B2201. The study was terminated early due to the efficacy results from an interim analysis of the Phase II study CQGE031B2201.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •forced Expiratory Volume in one second ( FEV1) >= 40% predicted
- •patients who completed CQGE031B2201 study
排除标准
- •life-threatening asthma attack, intubation, respiratory arrest during or after completion of CQGE031B2201 study
- •new malignancy
- •ongoing SAE from CQGE031B2201 that was assessed as related to study drug
- •patient experienced platelets drop to < 75,000/uL
- •patient experienced one unexpected grade 4 or two unexpected grade 3 hypersensitivity reactions
- •patient is pregnant
研究组 & 干预措施
QGE031 every 4 weeks (q4w)
Experimental
QGE031 240 mg subcutaneously q4w
干预措施: QGE031 (Drug)
结局指标
主要结局
Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability
时间窗: 52 weeks
Safety was monitored throughout the study.
次要结局
未报告次要终点
研究者
研究点 (1)
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