NCT00546143已完成4 期
Multi-center, Open-label, Multiple Dose Study in Mild to Moderate Asthmatics (With IgE/Body Weight Combinations Above That in the SmPC Dosing Table) to Determine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Omalizumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Safety and tolerability of omalizumab assessed by AEs and SAEs
研究概览
简要总结
This study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of allergic asthma >= 1 year duration and a history consistent with Step 2 or 3 clinical features from the Global Initiative for Asthma guidelines.
- •Eligible baseline serum immunoglobulin E (IgE) levels value and body-weight combinations
排除标准
- •Documented medical history of anaphylaxis
- •Lung disease other than mild to moderate allergic asthma such as chronic obstructive pulmonary disease (COPD)
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
Omalizumab 900 mg
干预措施: Omalizumab (Drug)
2
Experimental
Omalizumab 1050 mg
干预措施: Omalizumab (Drug)
3
Experimental
Omalizumab 1200 mg
干预措施: Omalizumab (Drug)
结局指标
主要结局
Safety and tolerability of omalizumab assessed by AEs and SAEs
次要结局
- - Pharmacokinetic/pharmacodynamic profile of multiple administrations of omalizumab to patients with mild to moderate allergic asthma - Pre-dose specific IgE levels
研究者
研究点 (3)
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