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An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia

NCT05426733 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-04-30

No results posted yet for this study

Summary

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia

Conditions

  • Biliary Atresia

Interventions

DRUG

Odevixibat

Odevixibat is a small molecule inhibitor of the ileal bile acid transporter (IBAT).

Sponsors & Collaborators

  • Albireo, an Ipsen Company

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2028-08-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • France
  • Germany
  • Italy
  • Malaysia
  • Netherlands
  • New Zealand
  • Poland
  • South Korea
  • Spain
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05426733 on ClinicalTrials.gov