NCT03859700已完成3 期
EPITOPE Open-label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of DBV712 in Peanut-Allergic Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 26
- 主要终点
- Proportion of subjects reaching an ED ≥1000 mg
研究概览
简要总结
Open-label, follow-up study for subjects who completed the EPITOPE study.
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
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •completion of the EPITOPE study
排除标准
- •Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches.
- •Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma
研究组 & 干预措施
DBV712 250mcg
Experimental
干预措施: DBV712 250 mcg (Biological)
结局指标
主要结局
Proportion of subjects reaching an ED ≥1000 mg
时间窗: 36 months
次要结局
- Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)(Throughout the study during 36 months)
研究者
研究点 (26)
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