NCT01259804已完成1 期
Efficacy and Safety of High-dose Peanut Oral Immunotherapy With Factors Predicting Outcome
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Pass/fail peanut challenge
研究概览
简要总结
Open pilot study of peanut oral immunotherapy in 22 children with peanut allergy
详细描述
Background Peanut allergy is severe and rarely resolves.
Objective To test the efficacy and safety of a new oral immunotherapy protocol for peanut allergy.
Method 22 peanut-allergic children will undergo oral challenge. Oral immunotherapy will be administered by gradual updosing with 2-weekly increments (8-38w) to 800mg protein (5 peanuts/day) followed by 30-weeks maintenance. Oral challenge will be repeated after 6 and 30 weeks maintenance.
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
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peanut allergy defined by oral challenge
排除标准
- •Major immunodeficiency
结局指标
主要结局
Pass/fail peanut challenge
时间窗: six months
次要结局
未报告次要终点
研究者
Dr. Andrew Clark
Consultant
Cambridge University Hospitals NHS Foundation Trust
研究点 (2)
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