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Enrolling By Invitation
NCT05426733
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
Conditions: Biliary Atresia
Sex: All
Healthy volunteers: No
Phase: PHASE3
Enrollment: 180
Sponsor: Albireo, an Ipsen Company
Location: Children's Hospital Colorado Aurora Colorado
Summary
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia
Eligibility Criteria
Inclusion Criteria:
* Completion of the 104-week Treatment Period of Study A4250-011
* Signed informed consent by caregiver
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT05426733). StuddyBuddy aggregates publicly available trial information.