Special Drug Use Observational Study of Xolair in Patients With Severe to Most Severe Seasonal Allergic Rhinitis Aged ≥ 12 Years and < 18 Years Whose Symptoms Were Inadequately Controlled Despite to Conventional Therapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportions of patients with Adverse events (AEs), Serious AEs, AEs leading to discontinuation of Xolair treatment, Adverse drug reactions (ADRs), Serious ADRs, ADRs leading to discontinuation of Xolair treatment
研究概览
简要总结
This was a multicenter, uncontrolled, open-label, special drug use study to investigate the safety and efficacy of Xolair by collecting data in its clinical setting in patients with severe to most severe seasonal allergic rhinitis aged ≥ 12 years and < 18 years whose symptoms were inadequately controlled despite to conventional therapies and used Xolair.
详细描述
The observation period lasted for up to 24 weeks, with Day 1 defined as the start date of Xolair treatment. It should be noted that, because the duration of Xolair treatment depends on the pollen dispersal situation and other factors, patients who completed or discontinued Xolair treatment before the visit at 24 weeks after the start of treatment were followed up until the date of last dose of Xolair + 30 days, and the results were recorded in the CRF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who used Xolair in accordance with the instructions of package insert
- •Patients aged ≥ 12 years and < 18 years at the start of Xolair
- •Patients who used Xolair for the following indication:
- •Indication: seasonal allergic rhinitis (only patients with severe to most severe symptoms whose symptoms were inadequately controlled despite to conventional therapies)
- •Patients having provided written consent to participate in this study before the start of Xolair in the relevant pollen season, in person and from their legally acceptable representative (legal representative)
排除标准
- •1. Patients with a history of hypersensitivity to any of the Xolair ingredients
研究组 & 干预措施
Xolair
S.C. Injection
干预措施: Xolair (Drug)
结局指标
主要结局
Proportions of patients with Adverse events (AEs), Serious AEs, AEs leading to discontinuation of Xolair treatment, Adverse drug reactions (ADRs), Serious ADRs, ADRs leading to discontinuation of Xolair treatment
时间窗: up to 24 weeks
The number of patients with each events and incidences (%) will be calculated by System Organ Class (SOC) and Preferred Term (PT). SAEs are defined as AEs meeting the criteria of seriousness and adverse events with a fatal outcome. ADRs are defined as AEs for which a causal relationship with Xolair is not ruled out by the investigator.
次要结局
- Overall improvement rate of disease by physicians(week 24)
- Disease severity of seasonal allergic rhinitis(Up to 24 weeks)
- Individual symptom severity of seasonal allergic rhinitis(Up to 24 weeks)