An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT)

Albireo AB0 个研究点目标入组 51 人开始时间: 2021年9月2日最近更新: 2024年4月15日

研究概览

暂无简介。

•1. Completion of the 24-week Treatment Period of Study A4250-012;
•2. 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;
•3. Caregivers (and age-appropriate patients) must be willing and able to use an electronic diary (eDiary) device as required by the study;
•4. 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;
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 51
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Decompensated liver disease, history or presence of clinically significant ascites, variceal hemorrhage, and/or encephalopathy;
•2. Patients who were not compliant with study drug treatment or procedures in Study A4250-012;
•3. 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;
•4. Known hypersensitivity to any components of odevixibat;

发起方