An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia (BOLD-EXT)
J
Jean Molleston, MD
Primary Investigator
Enrolling By Invitation
All
Phase
3
180 participants needed
2 Locations
Overview
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250)Children with Biliary Atresia
Description
This is a Phase 3, multi-center, open-label extension study to evaluate the long-termy and safety of odevixibat in patients with Biliary Atresia (BA). Patients whod treatment in the A4250-011 BOLD study and meet eligibility criteria for Study
A4250-016 (BOLD-EXT) can participate. The duration of the treatment period is 104 weeks,wed by a 4-week Safety Follow-up Period. Patients who wish to continue receivingdevixibat after 104 weeks can remain on treatment in the optional extension period (OEP).
Up to 180 patients will be enrolled at approximately 70 sites in the North America, Europe,he Middle East and Asia-Pacific.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Biliary Atresia
-
Gender: All
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 StudyA4250-011 as per the investigator's discretion
- Any conditions or abnormalities which, in the opinion of the investigator, mayhe safety of the patient, or interfere with the patient participating ing the study
- Known hypersensitivity to any components of odevixibat
- Patients who are scheduled for a liver transplant or are likely to require a liverhe immediate future based on the investigator's judgment
Updated on
15 May 2024.
Study ID: A4250-016
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