JPRN-jRCT2080221137未知3 期
A 24 week, open label, multi-center evaluation of pharmacokinetics and pharmacodynamics, efficacy and safety of omalizumab in Japanese children (6-15 years) with inadequately controlled allergic asthma despite current recommended treatment
ovartis Pharma K.K.0 个研究点目标入组 44 人开始时间: 2010年6月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 6age old 至 <= 15age old（—）
- 性别
- All
入选标准
- •Body weights and serum total IgE level within the dosing table range; body weight of 20 to 150 kg and serum total IgE levels of 30 to 1300 IU/mL
- •Receiving asthma long-term control medications of high dose ICS (>200 micro-g/day FP or equivalent) and two or more controller medications out of LTRA, theophylline, sodium cromoglycate,LABA, or OCSs 12 weeks prior to the run-in period. These medications should be kept stable for 4 weeks prior to the run-in period and during the run-in period (except for management of asthma attacks/exacerbations)
- •Having 2 or more asthma exacerbations requiring treatment with a doubling of the maintenance ICS dose for at least 3 days and/or systemic (oral or IV) corticosteroids in the past; one of these exacerbations must have occurred in the previous 12 months, which is documented in the medical record
- •Demonstrating inadequately controlled asthma symptoms during the last 14 day run-in period based on the patient diary
排除标准
- •With a history of food or drug related severe anaphylactoid or anaphylactic reaction(s)
- •With positive skin reaction to the study drug at the run-in period
- •With known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study drug or drug related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin)
- •With platelet level =< 100,000/micro-L at the run-in period
- •Who are taking intra-muscular depo-steroids within 4 weeks of the run-in period
- •Who are taking systemic (oral or IV) corticosteroids for reasons other than asthma within 4 weeks of the run-in period (patients with chronic OCSs use for asthma are allowed)
- •Other protocol-defined inclusion/exclusion criteria may apply
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