EUCTR2015-002461-37-DE进行中（未招募）1 期
A double-blind, placebo-controlled, randomized phase III pivotal trial to assess the efficacy and safety of peanut epicutaneous immunotherapy with viaskin peanut in peanut-allergic children
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
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
- •- Male or female children aged 4 through 11 years at Visit 1
- •- Physician-diagnosed peanut allergy or children with a well documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 330
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- History of severe anaphylaxis to peanut with any of the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence)
- •- Severe reaction during the entry/screening DBPCFC (defined as need for intubation, hypotension persisting after epinephrine administration, and/or the need for =3 doses of epinephrine), or if they have an objective IgE-mediated reaction to the placebo formula during the entry/screening DBPCFC.
研究者
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