EUCTR2009-014522-41-DE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
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.
- •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.Alcohol or drug abuse
- •4. Immunosuppressive treatment
- •5. Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis
- •6.Uncontrolled or severe asthma (FEV1 < 70% of predicted value after adequate pharmacologic treatment)
- •7.Pregnancy
- •8. Conditions or diseases which are contraindicated or otherwise not in line with the approved Grazax SmPC
- •9.Simultaneously participating in a different trial including a treatment intervention and/or an investigational medicinal product (IMP).
研究者
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