Status:
ENROLLING_BY_INVITATION
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
Lead Sponsor:
Albireo, an Ipsen Company
Conditions:
Biliary Atresia
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia
Detailed Description
This is a Phase 3, multi-center, open-label extension study to evaluate the long-term efficacy and safety of odevixibat in patients with Biliary Atresia (BA). Patients who completed treatment in the A...
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
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05426733
Start Date
July 5 2022
End Date
August 31 2028
Last Update
December 3 2025
Active Locations (30)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Children's Healhcare of Atlanta- Emory University school of medicine
Atlanta, Georgia, United States, 30322
3
Indiana University school of Medicine
Indianapolis, Indiana, United States, 46202
4
Boston Children's Hospital
Boston, Massachusetts, United States, 02115