CTIS2022-501090-39-00招募中1 期
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia (BOLD-EXT) - A4250-016
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Albireo AB
- 入组人数
- 184
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
- •1. Completion of the 104-week Treatment Period of Study A4250-011 22. Signed informed consent by the patient’s parent(s) or legal guardian
排除标准
- •1. Patients who were not compliant with study drug treatment or procedures in Study A4250-011 as per the investigator’s discretion 2. Any conditions or abnormalities which, in the opinion of the investigator, may compromise the safety of the patient, or interfere with the patient participating in or completing the study 3. Known hypersensitivity to any components of odevixibat 4. Patients who are scheduled for a liver transplant or are likely to require a liver transplant in the immediate future based on the investigator’s judgment
研究者
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