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

Enrolling by invitation · Phase 3

Conditions studied: Biliary Atresia

In brief

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

Key facts

Study ID

NCT05426733

Run by

Albireo, an Ipsen Company

People needed

180

Starts

2022-07-05

Expected to finish

2028-06-30

Last updated by the study team

2026-07-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completion of the 104-week Treatment Period of Study A4250-011
• Signed informed consent by caregiver

You may not qualify if…

• 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

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's Healhcare of Atlanta- Emory University school of medicine — Atlanta, Georgia, United States
• Indiana University school of Medicine — Indianapolis, Indiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Mercy Hospital and Clinics — Kansas City, Missouri, United States
• Hassenfeld Children's Hospital at NYU Langone — New York, New York, United States
• Columbia University Medical Center New York Presbyterian Morgan Stanley-Komansky Childrens Hospital — New York, New York, United States
• The Childrens Hospital at Montefiore Albert Einstein School of Medicine — The Bronx, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• 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

Full record on ClinicalTrials.gov

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