NCT06834165招募中4 期
A Phase IV Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 7
- 主要终点
- AEs after epinephrine treatment within 2 hours
研究概览
简要总结
The study is to assess the safety of neffy or IM Adrenalin in patients who are experiencing allergic reactions after an OFC, allergen Immunotherapy (AIT), or other allergy challenge that may require epinephrine intervention.
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
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a patient 4 years old or greater, inclusive, who are scheduled to undergo OFC, AIT, or other relevant allergy challenge.
- •Has body weight 15 kg or greater at the time of allergy challenge.
- •Is willing and able to provide written informed consent prior to participating in the study. In the case of minors (<18 years old), assent can be obtained from his/her legal representative, and as much possible from the patient himself/herself.
- •Patient experiences an allergic reaction that, in the opinion of the Investigator, requires treatment with epinephrine via neffy or IM Adrenalin.
排除标准
- •- Has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the Investigator.
研究组 & 干预措施
IM adrenaline
Active Comparator
干预措施: Adrenaline (Drug)
Neffy
Active Comparator
干预措施: Neffy (Drug)
结局指标
主要结局
AEs after epinephrine treatment within 2 hours
时间窗: 2 hours
次要结局
未报告次要终点
研究者
研究点 (7)
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