This study is in progress, not accepting new patients

Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome

Description

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

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

Approximately 35 sites will be initiated for this study in North America, Europe, Middle East, and Asia Pacific.

Alagille Syndrome, Syndrome, Odevixibat, Odevixibat (A4250)

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 hormonal contraception, intra-uterine device, or complete abstinence) from signed informed consent through 90 days after last dose of study drug.

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