NCT02396680已完成不适用
An Observational Follow-On Field Study to Evaluate the Continued Efficacy and Safety of Ragweed-SPIRE Treatment in Ragweed Allergic Subjects Approximately One Year After the Completion of Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 3
- 主要终点
- Total Rhinoconjunctivitis Symptom Score
研究概览
简要总结
The purpose of this study is to determine the efficacy of Ragweed-SPIRE 12 months after the initial dose.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •° Previously randomised into and completed at least 6 of 8 treatment visits in Study TR006
排除标准
- •Subject or Investigator have been informed of treatment received in Study TR006
- •Subjects with significant allergy to animal dander
- •Any allergen immunotherapy since completing Study TR006 or use of prohibited therapies
- •History of recurrent acute sinusitis or chronic sinusitis
- •Received treatment with an investigational drug within 4 weeks of Screening
- •Unable to understand study requirements or unable to communicate clearly with Investigator
结局指标
主要结局
Total Rhinoconjunctivitis Symptom Score
时间窗: Approximately 12 months after first dose in TR006
次要结局
- Rescue Medication Score(Approximately 12 months after first dose in TR006)
- Skin Prick Test(Approximately 12 months after first dose in TR006)
- Patient Global Assessment(Approximately 12 months after first dose in TR006)
- Immunoglobulin E Test(Approximately 12 months after first dose in TR006)
研究者
研究点 (3)
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