跳至主要内容
临床试验/EUCTR2009-014522-41-AT
EUCTR2009-014522-41-AT进行中(未招募)不适用

An interventional trial assessing the tolerability and safety of GRAZAX® in adults with grass pollen allergy

ALK-Abelló A/S0 个研究点目标入组 100 人开始时间: 2009年11月3日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100

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

  • Patients who meet each of the following criteria are eligible for the trial:
  • 1.Written informed consent obtained before entering the trial
  • 2.Willing and able to comply with the trial protocol regimen
  • 3.Participated in the GT-08 extension trial and received placebo treatment
  • 4.Will be prescribed Grazax in line with approved SmPC.
  • 5. Female subjects who are fertile will have to practice appropriate contraceptive methods for the duration of the trial
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Patients who meet one or more of the following criteria are excluded from the trial:
  • 1.History of allergy, hypersensitivity or intolerance to any of the excipients (except Phleum pratense)
  • 2.Malignancy or systemic diseases affecting the immune system e.g. autoimmune diseases, immune complex diseases or immune deficiency diseases
  • 3.Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis
  • 4.Uncontrolled or severe asthma (FEV1 < 70% of predicted value after adequate pharmacologic treatment)
  • 5.Pregnancy
  • 6.Simultaneously participating in a different trial including a treatment intervention and/or an investigational medicinal product (IMP).

研究者

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