EUCTR2016-004941-94-IT进行中（未招募）1 期
PEANUT ALLERGY ORAL IMMUNOTHERAPY STUDY OF AR101 FOR DESENSITIZATION IN CHILDREN AND ADULTS (PALISADE) FOLLOW-ON STUDY - PALISADE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Completion of ARC003
- •2. Written informed consent and/or assent from subjects/guardians as appropriate
- •3. Use of effective birth control by female subjects of child-bearing potential
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Early discontinuation from ARC003
- •2. Meets any longitudinally applicable ARC003 exclusion criteria
- •3. Failure to tolerate =443 mg cumulative of peanut protein with no or
- •mild symptoms in the ARC003 Exit DBPCFC (Group 2 only)
- •4. Any other condition that, in the opinion of the Investigator, precludes
- •participation for reasons of safety
研究者
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