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

Biliary Atresia Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

Up to 70 sites will be initiated for this study in North America, Europe, Middle East, and Asia Pacific. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04336722
Study type Interventional
Source Ipsen
Contact Ipsen Clinical Study Enquiries
Phone See email
Email clinical.trials@ipsen.com
Status Recruiting
Phase Phase 3
Start date July 8, 2020
Completion date July 31, 2026
View Details
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