NCT00807547已完成3 期
A Randomised, Parallel-group, Double-blind, Placebo-controlled, Multicentre Phase III Trial Assessing the Pharmacodynamic Efficacy and Safety of an Intra-seasonal Short-time Updosing Schedule for Alutard SQ
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Changes from baseline in Immuno globuline E (IgE)-blocking factor
研究概览
简要总结
Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of grass pollen induced allergic rhinoconjunctivitis
- •positive skin prick test
排除标准
- •uncontrolled severe bronchial asthma
- •previous treatment with immunotherapy within the previous 5 years
- •contraindication for specific immunotherapy
研究组 & 干预措施
Allergy vaccination
Active Comparator
Allergy vaccination by 6 subcutaneous injections to 10,000 SQ-U with 1-3 days intervals, continuation by 2 injections with 10,000 SQ-U with 2-4 weeks intervals
干预措施: Allergy vaccination (Alutard SQ) (Biological)
Subcutaneous injections
Placebo Comparator
Placebo injections
干预措施: Allergy vaccination (Alutard SQ) (Biological)
结局指标
主要结局
Changes from baseline in Immuno globuline E (IgE)-blocking factor
时间窗: 9 weeks
次要结局
- Tolerability(9 weeks)
研究者
研究点 (1)
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