EUCTR2013-003683-31-PL进行中（未招募）1 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Key Inclusion Criteria:
- •- FEV1 > 40% predicted
- •- patients who completed CQGE031B2201 study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Key Exclusion Criteria:
- •- 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
研究者
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