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Clinical trial

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia (BOLD-EXT)

ID
Name
A4250-016
Description
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia
Trial arms
Trial start
2022-07-05
Estimated PCD
2024-12-31
Trial end
2026-12-31
Phase
Early phase I
Treatment
Odevixibat
Odevixibat is a small molecule inhibitor of the ileal bile acid transporter (IBAT).
Arms:
Odevixibat (A4250)
Other names:
A4250
Size
180
Primary endpoint
Proportion of patients who are alive and have not undergone liver transplant
From baseline to Week 104
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}
Updated at
2024-04-29

1 organization

1 product

1 indication

Product
Odevixibat
Indication
Biliary Atresia
Organization
Albireo