JPRN-jRCT2080221414未知3 期
An extension study to CIGE025B1301 to evaluate the long-term safety, tolerability and efficacy of omalizumab in Japanese children
ovartis Pharma K.K.0 个研究点目标入组 35 人开始时间: 2011年3月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 35
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 <= 16age old（—）
- 性别
- All
入选标准
- •1.Patients who completed the core study (IGE025B1301) and who in the investigator's clinical judgment could benefit from continuous treatment of the study drug.
排除标准
- •1.Patients who currently have diagnosed cancer, are currently being investigated for possible cancer or have any history of cancer.
- •2.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are
- •-women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
- •-women whose partners have been sterilized by vasectomy or other means
- •-using a highly effective method of birth control agreeing on total abstinence and the investigator also judges that the age, career lifestyle or sexual orientation of the patient ensures compliance
- •3.With clinically significant uncontrolled systemic disease (eg: infection, hematological disease, renal, hepatic, coronary heart disease or other cardiovascular disease, cerebro-vascular, endocrinologic or gastrointestinal disease) after the treatment period of the core study
- •4.Patients with a history of major protocol violations during the core study and who are considered potentially unreliable as judged by the investigator at each site
研究者
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