NCT01454531已完成2 期
An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy
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
- 199
- 试验地点
- 20
- 主要终点
- Frequency of Subjects With Adverse Drug Reactions
研究概览
简要总结
The purpose of this study is to assess the tolerability of AVANZ.
详细描述
To assess the tolerability of the up-dosing phase of AVANZ Phleum pratense. The frequency of patients with adverse reactions will be the study primary endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 rhinoconjunctivitis
- •Positive SPT to Phleum pratense
- •Positive specific IgE against Phleum pratense
排除标准
- •Uncontrolled severe asthma
研究组 & 干预措施
AVANZ Phleum pratense
Experimental
AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
干预措施: AVANZ Phleum pratense (Drug)
结局指标
主要结局
Frequency of Subjects With Adverse Drug Reactions
时间窗: 6 weeks
Frequency of patients with adverse reactions, local or systemic
次要结局
- Change in Phleum Pratense Specific IgE-blocking Factor(baseline (visit 1) and at 6 weeks (visit 6))
- Frequency of Subjects With Systemic Reactions(6 weeks)
- Frequency of Subjects With Local Adverse Reaction(6 weeks)
- Change in Phleum Pratense Specific IgG4(baseline (visit 1) and at 6 weeks (visit 6))
- Change in Immediate Cutaneous Response to Phleum Pratense(baseline (visit 1) and at 6 weeks (visit 6))
研究者
研究点 (20)
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