An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia (BOLD-EXT)
Status: Enrolling_by_invitation
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Completion of the 104-week Treatment Period of Study A4250-011
• Signed informed consent by caregiver
Locations
United States
Colorado
Children's Hospital Colorado
Aurora
Georgia
Children's Healhcare of Atlanta- Emory University school of medicine
Atlanta
Indiana
Indiana University school of Medicine
Indianapolis
Massachusetts
Boston Children's Hospital
Boston
Missouri
Children's Mercy Hospital and Clinics
Kansas City
New York
Columbia University Medical Center New York Presbyterian Morgan Stanley-Komansky Childrens Hospital
New York
Hassenfeld Children's Hospital at NYU Langone
New York
The Childrens Hospital at Montefiore Albert Einstein School of Medicine
The Bronx
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Washington
Seattle Children's Hospital
Seattle
Other Locations
Australia
Royal Children's Hospital
Parkville
Canada
CHU Sainte-Justine
Montreal
The Hospital for Sick Children
Toronto
China
Guangzhou Women And Childrens Medical Center
Guangdong
Children's Hospital of Fudan University
Shanghai
France
Bicêtre Hospital
Le Kremlin-bicêtre
Germany
Charité - Universitätsmedizin Berlin
Berlin
University Children´s Hospital Tuebingen
Tübingen
Italy
ASST Papa Giovanni XXIII
Bergamo
Azienda Ospedaliera di Padova
Padua
Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu
University Malaya Medical Centre
Kuala Lumpur
Netherlands
University Medical Center Groningen
Groningen
New Zealand
Starship Child Health, Te Whatu Ora - Health New Zealand
Auckland
Poland
Instytut Pomnik-Centrum Zdrowia Dziecka
Warsaw
Republic of Korea
Seoul National University Childrens Hospital
Seoul
Spain
Hospital Universitari Vall d'Hebron
Barcelona
Turkey
Hacettepe İhsan Doğramacı Children's Hospital
Ankara
Akdeniz University Medical Faculty
Antalya
Istanbul University Istanbul Medical Faculty Hospital
Istanbul
Time Frame
Start Date: 2022-07-05
Completion Date: 2028-08-31
Participants
Target number of participants: 180
Treatments
Experimental: Odevixibat (A4250)
Capsules for oral administration once daily for 104 weeks.
Related Therapeutic Areas
Sponsors
Leads: Albireo, an Ipsen Company