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

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

Outcome

Missed primary endpoint

release “BOLD trial evaluating Bylvay® (odevixibat) versus placebo in patients with biliary atresia who had already undergone a Kasai hepatoportoenterostomy did not meet its primary endpoint” ipsen.com ↗

Drugs

Indications