NCT02300701已完成4 期
The Role of Anti-IgE (Omalizumab) in the Management of Severe Recalcitrant Paediatric Atopic Eczema
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Improvement in atopic eczema
研究概览
简要总结
To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema.
详细描述
To address the value of anti-IgE in children with severe eczema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 4-19 years
- •Severe eczema
- •Raised SpIgE or SPT to at least 1 food allergen or 1 aeroallergen AND/OR
- •Clinical impression that allergic exposures cause worsening eczema.
- •Total IgE level >300 kU/l
- •Clinically proven IgE-mediated allergic disease.
- •Written informed consent to participate.
- •Exclusion criteria:
- •Inability to comply with 2-4 weekly injections and clinic visits
- •Evidence of underlying immune compromise, autoimmune disease, immune complex mediated conditions.
- •Uncontrolled infection or unstable eczema.
- •Malignancy or a history of malignancy.
- •Pre-existing hepatic or renal impairment
- •Known cardiovascular or ischaemic cerebrovascular abnormality.
- •Other serious or uncontrolled systemic disease.
- •Pregnancy or lactation.
- •Known history of hypersensitivity or anaphylaxis to anti-IgE injections or its constituents.
- •Insufficient understanding of the trial assessments.
- •Participation in a CTIMP in the previous 60 days or (if known) 4 half-lives of the relevant medication, whichever is the greater.
- •Investigator feels that there is a good clinical reason why the child would be unsuitable.
排除标准
- 未提供
研究组 & 干预措施
Xolair/Omalizumab
Experimental
干预措施: Xolair (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in atopic eczema
时间窗: 24 weeks after treatment commences
次要结局
未报告次要终点
研究者
研究点 (1)
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