- ongoing, recruitingPhase II and Phase III (Integrated)
A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Obeticholic Acid Compared to Placebo in Pediatric Subjects with Biliary Atresia, Post-hepatoportoenterostomy
This study is testing a new medicine, obeticholic acid (OCA), for children and young adults with biliary atresia who have had a specific surgery. We want to see if OCA can help slow down liver disease and improve their health.
Belgium · Germany · Netherlands - active not recruitingPHASE3
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
This study is testing a new medicine, Odevixibat, for babies with a liver problem called Biliary Atresia. It aims to see if the medicine is safe and helps after a special operation called a Kasai procedure.
United States · Australia · Belgium