An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children… (NCT05426733) | Clinical Trial Compass
By InvitationPhase 3
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia
United States180 participantsStarted 2022-07-05
Plain-language summary
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia
Who can participate
SexALL
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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
What they're measuring
1
Proportion of patients who are alive and have not undergone liver transplant