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临床试验/EUCTR2012-005092-14-ES
EUCTR2012-005092-14-ES进行中(未招募)1 期

Molecular and Cellular Mechanism in the course of Immunotherapy with a Phleum pratense oral lyophilisate

ALK-Abelló S.A.0 个研究点目标入组 50 人开始时间: 2013年1月11日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
50

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.A history of relevant rhinitis or rhinoconjunctivitis with or without asthma due to grass pollen since at least the pollen season prior to trial entry (GPS 2012).
  • 2.Documented positive specific IgE against Phl p 5 (above or equal to IgE Class 2, above or equal to 0.70 kU/l).
  • 3.Positive Skin Prick Test (SPT) response (wheal diameter above or equal 3 mm) to Phleum pratense (ALK-Abelló).
  • Are the trial subjects under 18? no
  • 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 50
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.Previous treatment by immunotherapy with grass allergen extracts.
  • 2.Ongoing treatment with any allergen specific immunotherapy product.
  • 3.Previous or ongoing treatment with Omalizumab, mono amine oxidase (MAO) inhibitors or tricyclic antidepressant medication.

研究者

发起方
ALK-Abelló S.A.

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