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Enrolling by invitation Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05426733

Public ClinicalTrials.gov record NCT05426733. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jun 26, 2026, 7:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT05426733
Recruitment status
Enrolling by invitation
Study type
Interventional
Phase
Phase 3
Lead sponsor
Albireo, an Ipsen Company
Industry
Enrollment
180 participants

Conditions and interventions

Interventions

  • Odevixibat Drug

Drug

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 4, 2022
Primary completion
Jun 29, 2028
Completion
Jun 29, 2028
Last update posted
May 27, 2026

2022 – 2028

United States locations

U.S. sites
10
U.S. states
8
U.S. cities
9
Facility City State ZIP Site status
Children's Hospital Colorado Aurora Colorado 80045
Children's Healhcare of Atlanta- Emory University school of medicine Atlanta Georgia 30322
Indiana University school of Medicine Indianapolis Indiana 46202
Boston Children's Hospital Boston Massachusetts 02115
Children's Mercy Hospital and Clinics Kansas City Missouri 64108
Hassenfeld Children's Hospital at NYU Langone New York New York 10016
Columbia University Medical Center New York Presbyterian Morgan Stanley-Komansky Childrens Hospital New York New York 10032
The Childrens Hospital at Montefiore Albert Einstein School of Medicine The Bronx New York 10467
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229
Seattle Children's Hospital Seattle Washington 98105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05426733, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 27, 2026 · Synced Jun 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05426733 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →