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

This is a Phase 3, multi-center, open-label extension study to evaluate the long-term efficacy and safety of a 120 [MICRO-SYMBOL]g/kg/day dose of odevixibat in patients with BA. Patients who completed treatment in Study A4250-011 and meet eligibility criteria for Study A4250-016 are eligible to participate. The duration of the treatment period is 104 weeks, followed by a 4-week Safety Follow-up Period. Clinic visits will occur every 4 to 13 weeks up to Week 52 then every 26 weeks up until Week 104.