DRKS00003280已完成4 期
The influence of omalizumab (Xolair ) on the composition of intracellular granules and Degranulationsschwelle of skin mast cells and peripheral basophils before and during omalizumab therapy in patients with chronic urticaria - OTTO
niversitätsklinikum MagdeburgDekan0 个研究点目标入组 24 人开始时间: 2011年10月12日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •intermittent or persistent symptoms of chronic urticaria and / or angioedema for at least 6 weeks to treat refractory stage 3 of the international guideline CU, or
- •- Persistent symptoms of AD with / without allergic / s asthma despite treatment with topical steroids drug class two and systemic therapy with antihistamines.
- •- The / the patient / in is able to understand the study, to give his / her consent and is available for the study duration.
- •- Written consent after thorough verbal and written explanation is given.
排除标准
- •- Hypersensitivity to omalizumab or Xolair one of the ingredients.
- •- Xolair therapy in history
- •- Immunosuppressive medication 4 weeks before study entry
- •- Acute asthma exacerbations, acute bronchospasm, status asthmaticus
- •- Pregnancy
- •- Severe other diseases: for example HIV, chronic hepatitis B / C, severe autoimmune disease or with pre-existing renal or hepatic dysfunction.
- •- Non-compliance and / or inability to understand the context in the study required information.
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