CTIS2022-502917-27-00招募中1 期
ongterm, openlabel (doseblinded), extension study of eptinezumab in children and adolescents with chronic or episodic migraine - 19379A
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 600
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
- 0 至 17（—）
- 性别
- All
入选标准
- •The patient must have completed Week 12 (completion) Visit of either Study 19356A (CM) or Study 19357A (EM) immediately prior to enrolment into this OLE study.
排除标准
- •The patient has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator., During lead-in Study19356A or Study19357A: - participant experienced anaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator. - the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value >5 times the upper limit of the reference range that was confirmed by testing <2 weeks later. - the participant had a serum ALT or AST value >3times the upper limit of the reference range and a serum total bilirubin value >2times the upper limit of the reference range.
研究者
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