Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

Phase 3 Completed 254 enrolled Albireo, an Ipsen Company

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2020-07-08
Primary completion: 2026-06-22
Completion: 2026-06-22

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Odevixibat	Small molecule	—	Oral

Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

Summary

Timeline

Drugs

Indications