Influence of Omalizumab Co-treatment on Honey-bee Venom Immunotherapy Failure Due to Systemic Reactions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment.
研究概览
简要总结
The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to systemic reactions.
详细描述
Some honey bee venom allergic patients cannot be treated with venom immunotherapy due to systemic reactions during immunotherapy - immunotherapy failure due to systemic reactions. High basophil allergen sensitivity is a risk factor for venom immunotherapy failure due to systemic reactions. Omalizumab decreases basophil sensitivity. Venom immunotherapy failure patients will be co-treated with omalizumab during another attempt of immunotherapy introduction. Patients will be clinically and immunologically followed up after the introduction.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe anaphylactic reaction after honey-bee sting (Mueller grade III or IV) confirmed sensitization to honey-bee venom,
- •honey-bee venom immunotherapy treatment failure due to systemic reactions.
排除标准
- •systemic mastocytosis,
- •pregnancy,
- •use of beta-adrenergic blocking agents.
研究组 & 干预措施
NEVIT
Co treatment with omalizumab during another attempt of immunotherapy introduction
干预措施: omalizumab (Drug)
结局指标
主要结局
Number of systemic reactions during ultra rush immunotherapy build up phase and maintenance phase followed by omalizumab co-treatment.
时间窗: 2 months
次要结局
- Changes in basophil sensitivity during omalizumab co-treatment(2 years)