NCT01510626已完成1 期
Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Number of adverse events in the treatment population
研究概览
简要总结
The long-term goal of the investigators study is to develop a better and safer treatment for, and to potentially cure patients with single or multiple food allergies. The investigators hypothesize that the application of this protocol will allow patients with severe and single or multiple food allergies to be safely and rapidly desensitized.
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
- 4 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old.
- •Sensitivity to food allergen will be documented by a positive skin prick test result or allergen-specific ImmunoCAP IgE level, with 7 kU/L as a lower limit of eligibility.
排除标准
- •No absolute contraindications are known. However, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers).
- •Subjects with a total IgE at screening of >2,000 kU/L
- •Previous reaction to omalizumab
- •Subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.
研究组 & 干预措施
One
Experimental
干预措施: Food proteins (Dietary Supplement)
One
Experimental
干预措施: Omalizumab (Drug)
结局指标
主要结局
Number of adverse events in the treatment population
时间窗: 2 years
次要结局
- Number of subjects who reach 2g or more of food flour(2 years)
研究者
Kari Christine Nadeau
Associate Professor
Stanford University
研究点 (1)
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