NCT05426733
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
Enrolling by Invitation
PHASE3All AgesInterventionalTreatmentAlbireo, an Ipsen Company
~180 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Odevixibat
At a glance
Recruiting sites
0 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients who are alive and have not undergone liver transplant
Measured over From baseline to Week 104
Conditions
Where it's being run
30 sites across 21 statesNew York3
Turkey (Türkiye)3
Canada2
China2
Germany2
Italy2
Malaysia2
Colorado1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Completion of the 104-week Treatment Period of Study A4250-011
Signed informed consent by caregiver
Exclusion
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
What this trial measures
- Proportion of patients who are alive and have not undergone liver transplantFrom baseline to Week 104