Intra-lymphatic Immunotherapy for the Management of Peanut Allergy
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Peanut tolerance
研究概览
简要总结
Use of three intralymphatic injections of peanut allergen one month apart to induce tolerance to peanut in peanut allergic people.
详细描述
Eligible subject undergo a baseline blinded oral peanut challenge. Then the peanut ILIT as described above. Pretreatment with antihistamines, leukotriene modifier and albuterol before each treatment.
Following the three ILIT peanut injections a repeat blinded oral peanut challenge is performed.
Blood is drawn at each of the 5 study visits for a variety of tests trying to elucidate the mechanism(s) of the induction of tolerance to peanut.
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
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of peanut allergy Positive prick skin tests or invitro IgE to peanut Positive blinded oral peanut challenge.
排除标准
- •life threatening anaphylaxis to peanut Uncontrolled asthma
结局指标
主要结局
Peanut tolerance
时间窗: 4 months
Increase in amount (mg - grams) of peanut ingested without reaction from baseline to one month post ILIT
次要结局
未报告次要终点
研究者
Ronald A Simon
Emeritus Head, Division of Asthma, Allergy and Immunology
Scripps Health