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

a study on Biliary Atresia

Summary

Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

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

Details

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

Keywords

Biliary Atresia Kasai Odevixibat Odevixibat (A4250)

Eligibility

You can join if…

  • A male or female patient with a clinical diagnosis of BA
  • Age at Kasai HPE ≤90 days
  • Eligible to start study treatment within 3 weeks post-Kasai HPE

You CAN'T join if...

  • Patients with intractable ascites
  • Ileal resection surgery
  • ALT ≥10× upper limit of normal (ULN) at screening
  • Patient on total parenteral nutrition at randomization
  • Acute ascending cholangitis (patients may be randomized after resolution of acute ascending cholangitis)
  • Choledochal cystic disease

Locations

  • UCSF Benioff Children's Hospital San Francisco accepting new patients
    San Francisco California 94158 United States
  • Indiana University school of Medicine accepting new patients
    Indianapolis Indiana 46202 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Albireo
ID
NCT04336722
Phase
Phase 3
Study Type
Interventional
Last Updated
Contact us about this trial