NCT00800332已完成2 期
Double-blind, Placebo-controlled Dose-finding Study With CYT003-QbG10 in Adult Patients With Rhinoconjunctivitis Due to House Dust Mite Allergy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Rhinoconjunctivitis symptom and medication scores
研究概览
简要总结
The purpose of the study is to test whether vaccinations with CYT003-QbG10 can improve allergy symptoms in patients with house dust mite allergy. The active treatment will be compared against placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens
- •Further criteria as defined in the study protocol
排除标准
- •Clinically manifested seasonal allergy/-ies which is/are expected to interfere with the patient's study treatment schedule and/or assessments
- •Clinically relevant perennial allergy/-ies other than house dust mites allergy
- •Contraindication to any study test or procedure
- •Further criteria as defined in the study protocol
研究组 & 干预措施
1
Experimental
干预措施: CYT003-QbG10 (Drug)
2
Experimental
干预措施: CYT003-QbG10 (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Rhinoconjunctivitis symptom and medication scores
时间窗: Pre- / Post-Treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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