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

NCT04336722 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

  • Biliary Atresia

Interventions

DRUG

Odevixibat

Odevixibat is a small molecule and selective inhibitor of IBAT.

DRUG

Placebo

Placebo identical in appearance to experimental drug (odevixibat).

Sponsors & Collaborators

  • Albireo, an Ipsen Company

    lead INDUSTRY

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
111 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-08
Primary Completion
2026-06-26
Completion
2026-06-26
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs

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 NCT04336722 on ClinicalTrials.gov