- ClinicalTrials.gov ID: NCT05426733
- Recruiting participants (Starts Aug. 30, 2023)
- Not accepting healthy volunteers
- UTSW Principal Investigator: AMAL AHMAD IBRAHIM AQUL
summary
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.
objective
To demonstrate a sustained effect of odevixibat on survival with native liver in children with biliary atresia (BA) who have completed study A4250-011 (BOLD)