clinical trial · NCT04336722
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
Albireo, an Ipsen Company·phase3·active not recruiting·n = 254
Biliary AtresiaOdevixibatPlacebo
brief summary
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.
started
Jul 8, 2020
primary completion
Jun 26, 2026
completion
Jun 26, 2026
last updated
Apr 1, 2026
detailed description
Up to 70 sites will be initiated for this study in North America, Europe, Middle East, and Asia Pacific.
official title
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol