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临床试验/EUCTR2006-002771-40-SE
EUCTR2006-002771-40-SE进行中(未招募)不适用

Importance of IgE antibody fraction size on allergen sensitivity of basophils from cat allergic patients on Xolair. A pilot study.

S.G.O. Johansson, MD PhD Professor0 个研究点开始时间: 2006年7月5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)
发起方

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 clinical history of allergic asthma and/or rhinitis
  • 2.IgE –antibodies to cat
  • 3.total serum IgE level between 30 and 700 kU/L
  • 4.percent IgE antibodies to cat < 0.7% (Low group) or > 5.5% (High group)
  • 5.body weights: 40-150 kg
  • 6.adult outpatients of both sexes
  • 7.fulfil the general criteria, e.g health, non-pregnancy, for receiving Xolair for treatment of allergic asthma
  • 8. written informed consent.
  • 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

  • 1.not subject to previous or ongoing ASIT with cat dander allergen.
  • 2.previously randomized into this or any other omalizumab study or who have received omalizumab by prescription.
  • 3. with known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication or drugs related to omalizumab (e.g.: monoclonal antibodies, polyclonal gamma globulin).
  • 4.not be on treatment with oral corticosteroids or be judged to need such treatment during the trial.

研究者

发起方
S.G.O. Johansson, MD PhD Professor

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