An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia

• Status: Enrolling by invitation
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia

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

Details

• Lead Sponsor: Albireo

Criteria

Inclusion Criteria:

• Completion of the 104-week Treatment Period of Study A4250-011

• Signed informed consent by caregiver

Exclusion Criteria:

• Patients who were not compliant with study drug treatment or procedures in Study A4250-011 as per the investigator's discretion

• 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

• Known hypersensitivity to any components of odevixibat

• 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