EUCTR2021-002533-42-Outside-EU/EEA进行中（未招募）1 期
Oral Desensitization to Peanut in Peanut-AllergicChildren and Adults Using Characterized PeanutAllergen (CPNA) Peanut Oral Immunotherapy (OIT)Safety Follow-On Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Completion of study ARC001
- •Written informed consent from subject and/or parent/guardian
- •Written assent from all subjects as appropriate
- •Use of birth control for females of child-bearing potential
- •No change in the status of any longitudinally applicable ARC001
- •inclusion criteria
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Early termination from ARC001
- •For former active AR101 (CPNA) treatment subjects from ARC001
- •(Group 2), failure to tolerate with no or mild symptoms 300 mg of peanut
- •protein in their ARC001 exit DBPCFC
- •Pregnancy or lactation
- •For former placebo subjects from ARC001 (Group 1), a lapse in dosing of
- •more than 10 days from completion of ARC001
- •Change in the status of any longitudinally applicable ARC001 exclusion criteria
研究者
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