CTIS2023-509028-17-00招募中1 期
An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT) - A4250-015
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
- 50
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 64（—）
- 性别
- All
入选标准
- •Completion of the 24-week Treatment Period of Study A4250-012;, Signed informed consent and assent as appropriate. Patients who turn 18 years of age (or legal age per country) during the study will be required to re-consent to remain on the study;, Caregivers (and age-appropriate patients) must be willing and able to use an electronic diary (eDiary) device as required by the study;, Sexually active males and females must agree to use a reliable contraceptive method with = 1% failure rate (such as intra-uterine device or complete abstinence) from signed informed consent through 90 days after last dose of study drug;
排除标准
- •Decompensated liver disease, history or presence of clinically significant ascites, variceal hemorrhage, and/or encephalopathy;, Patients who were not compliant with study drug treatment or procedures in Study A4250-012;, Any other 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;, Known hypersensitivity to any components of odevixibat;
研究者
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