NCT00554983已完成3 期
A Multicentre Randomised Placebo-controlled Double-blind Pivotal Clinical Trial for the Evaluation of Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, rBet v 1-FV
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Symptom-Medication-Score
研究概览
简要总结
Efficacy and Safety from a recombinant folding variant of Bet v 1
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergic rhinoconjunctivitis attributable to birch pollen
- •Positive SPT
- •Positive EAST
- •Positive specific provocation test
排除标准
- •Serious chronic diseases
- •Other perennial allergies
研究组 & 干预措施
2
Placebo Comparator
干预措施: placebo (Biological)
1
Experimental
干预措施: recombinant birch pollen allergen (Biological)
结局指标
主要结局
Symptom-Medication-Score
时间窗: during pollen season
次要结局
未报告次要终点
研究者
研究点 (1)
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