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ENROLLING BY INVITATION
NCT05426733
PHASE3

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

Sponsor: Albireo, an Ipsen Company

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2022-07-05

Completion Date

2028-08-31

Last Updated

2026-04-01

Healthy Volunteers

No

Conditions

Interventions

DRUG

Odevixibat

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

Locations (30)

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

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)