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

NCT05426733 · tracked via the Priya Life Science USA tracker

Sponsor

Albireo, an Ipsen Company

Phase

Phase 3

Started

2022-07-05

Last updated

2026-08-31

Condition(s) studied

Biliary Atresia

Investigational drug(s) / intervention(s)

Odevixibat

Odevixibat: Odevixibat is a small molecule inhibitor of the ileal bile acid transporter (IBAT).

Study summary

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

Eligibility

Sex

ALL

Min age

—

Max age

—

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

Primary outcome measure(s)

Proportion of patients who are alive and have not undergone liver transplant — From baseline to Week 104

Trial sites (30)

Facility	City	Region
Children's Hospital Colorado	Aurora	Colorado
Children's Healhcare of Atlanta- Emory University school of medicine	Atlanta	Georgia
Indiana University school of Medicine	Indianapolis	Indiana
Boston Children's Hospital	Boston	Massachusetts
Children's Mercy Hospital and Clinics	Kansas City	Missouri
Hassenfeld Children's Hospital at NYU Langone	New York	New York
Columbia University Medical Center New York Presbyterian Morgan Stanley-Komansky Childrens Hospital	New York	New York
The Childrens Hospital at Montefiore Albert Einstein School of Medicine	The Bronx	New York
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
Seattle Children's Hospital	Seattle	Washington
Royal Children's Hospital	Parkville	Australia
CHU Sainte-Justine	Montreal	Canada
The Hospital for Sick Children	Toronto	Canada
Guangzhou Women And Childrens Medical Center	Guangdong	China
Children's Hospital of Fudan University	Shanghai	China
Bicêtre Hospital	Le Kremlin-Bicêtre	France
Charité - Universitätsmedizin Berlin	Berlin	Germany
University Children´s Hospital Tuebingen	Tübingen	Germany
ASST Papa Giovanni XXIII	Bergamo	Italy
Azienda Ospedaliera di Padova	Padova	Italy
Hospital Raja Perempuan Zainab II	Kota Bharu	Malaysia
University Malaya Medical Centre	Kuala Lumpur	Malaysia
University Medical Center Groningen	Groningen	Netherlands
Starship Child Health, Te Whatu Ora - Health New Zealand	Auckland	New Zealand
Instytut Pomnik-Centrum Zdrowia Dziecka	Warsaw	Poland
Seoul National University Childrens Hospital	Seoul	South Korea
Hospital Universitari Vall d'Hebron	Barcelona	Spain
Hacettepe İhsan Doğramacı Children's Hospital	Ankara	Turkey (Türkiye)
Akdeniz University Medical Faculty	Antalya	Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty Hospital	Istanbul	Turkey (Türkiye)

More Albireo, an Ipsen Company trials in the USA

Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05426733 on ClinicalTrials.gov ↗ ← All trials in the USA