NCT02916446已完成3 期
Safety Study of Viaskin Peanut to Treat Peanut Allergy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 393
- 试验地点
- 32
- 主要终点
- Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This study evaluates the safety of Viaskin Peanut 250 mcg in the treatment of peanut allergy in children from 4 to 11 years of age. Subjects will receive either Viaskin Peanut 250 mcg or a placebo for a period of 6 months, after which all subjects will be receiving the active treatment up to a period of 3 years under active treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed peanut allergy;
- •A peanut Skin Prick Test (SPT) with a wheal largest diameter ≥8 mm;
- •A specific-peanut Immunoglobulin E (IgE) ≥14 kU/L;
- •Subjects following a strict peanut-free diet.
排除标准
- •Generalized dermatologic disease
- •Spirometry forced expiratory volume in 1 second (FEV1) <80% of the predicted value, or peak expiratory flow (PEF) <80% of predicted value;
- •Receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy; anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy;
- •Prior or concomitant history of any immunotherapy to any food allergy (for example EPIT, OIT, SLIT, or specific oral tolerance induction).
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo patch, daily administration
干预措施: Placebo (Biological)
Viaskin Peanut 250 mcg
Experimental
Viaskin Peanut 250 mcg, daily administration
干预措施: Viaskin Peanut 250 mcg (Biological)
结局指标
主要结局
Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Through study completion, an average of 3 years
次要结局
未报告次要终点
研究者
研究点 (32)
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