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

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

July 5, 2022

Primary Completion Date

July 31, 2028

Study Completion Date

August 31, 2028

Conditions
Biliary Atresia
Interventions
DRUG

Odevixibat

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

Trial Locations (30)

1023

Starship Child Health, Te Whatu Ora - Health New Zealand, Auckland

3052

Royal Children's Hospital, Parkville

10016

Hassenfeld Children's Hospital at NYU Langone, New York

10032

Columbia University Medical Center New York Presbyterian Morgan Stanley-Komansky Childrens Hospital, New York

10467

The Childrens Hospital at Montefiore Albert Einstein School of Medicine, The Bronx

30322

Children's Healhcare of Atlanta- Emory University school of medicine, Atlanta

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Indiana University school of Medicine, Indianapolis

59100

University Malaya Medical Centre, Kuala Lumpur

64108

Children's Mercy Hospital and Clinics, Kansas City

80045

Children's Hospital Colorado, Aurora

98105

Seattle Children's Hospital, Seattle

02115

Boston Children's Hospital, Boston

Unknown

CHU Sainte-Justine, Montreal

The Hospital for Sick Children, Toronto

Guangzhou Women And Childrens Medical Center, Guangdong

Children's Hospital of Fudan University, Shanghai

Bicêtre Hospital, Le Kremlin-Bicêtre

Charité - Universitätsmedizin Berlin, Berlin

University Children´s Hospital Tuebingen, Tübingen

ASST Papa Giovanni XXIII, Bergamo

Azienda Ospedaliera di Padova, Padua

Hospital Raja Perempuan Zainab II, Kota Bharu

University Medical Center Groningen, Groningen

Instytut Pomnik-Centrum Zdrowia Dziecka, Warsaw

Seoul National University Childrens Hospital, Seoul

Hospital Universitari Vall d'Hebron, Barcelona

Hacettepe İhsan Doğramacı Children's Hospital, Ankara

Akdeniz University Medical Faculty, Antalya

Istanbul University Istanbul Medical Faculty Hospital, Istanbul

All Listed Sponsors
lead

Albireo, an Ipsen Company

INDUSTRY