An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia (BOLD-EXT)
BOLD OLE
What is the goal of the study?
This is a Phase 3, multi-center, open-label extension study to evaluate the long-term efficacy and safety of a 120 μg/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. Patients who wish to continue receiving odevixibat after 104 weeks will have the option to remain on treatment in an optional extension period (OEP) with clinic visits every 26 weeks provided continued use is supported by the risk-benefit profile and the patient has not been previously withdrawn or discontinued from the study
Who can participate in the study?
Please contact the study team listed below to learn more.