NCT00671268已完成3 期
Multicentre, Multinational Randomised DBPC Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Change of Symptom and Medication score
研究概览
简要总结
Efficacy and Safety from a high-dosed subcutaneous recombinant preparation
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 grass pollen
- •Positive SPT
- •Positive EAST
- •Positive provocation test
排除标准
- •serious disease
- •other perennial allergies
研究组 & 干预措施
1
Experimental
strict subcutaneous
干预措施: AL0704rP (Biological)
2
Placebo Comparator
strict subcutaneous
干预措施: Placebo (Biological)
结局指标
主要结局
Change of Symptom and Medication score
时间窗: during the baseline and the following two pollen seasons
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture SurgeryVenous ThromboembolismNCT00709904Sanofi469
已完成
3 期
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal SurgeryVenous ThromboembolismNCT00679588Sanofi4,413
已完成
3 期
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture SurgeryVenous ThromboembolismNCT00721760Sanofi1,003
终止
3 期
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted MobilityVenous ThromboembolismNCT00714597Sanofi421
Unknown
3 期
Efficacy and Safety of Sublingual Immunotherapy (SLIT)Allergic RhinitisNCT01012882Roxall Medizin120