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

• Status: Enrolling by invitation
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albireo

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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