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

Albireo, an Ipsen Company

Status and phase

Invitation-only

Phase 3

Conditions

Biliary Atresia

Treatments

Drug: Odevixibat

Study type

Interventional

Funder types

Industry

Identifiers

NCT05426733

A4250-016

2022-501090-39-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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

Full 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 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, followed by a 4-week Safety Follow-up Period. Patients who wish to continue receiving odevixibat 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, the Middle East and Asia-Pacific.

Enrollment

180 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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