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临床试验/EUCTR2016-004941-94-ES
EUCTR2016-004941-94-ES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

Aimmune Therapeutics, Inc.0 个研究点目标入组 500 人开始时间: 2017年3月7日最近更新:
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

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: 400
  • 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 > or = 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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