CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 62 enrolled
Drug / intervention
A4250 (odevixibat) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03566238
NCT03566238Phase 3Completed
CompareCT.gov

A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)

Albireo·interventional·Posted Jun 25, 2018·Updated Nov 28, 2025

In Brief

A Phase 3 clinical trial evaluating A4250 (odevixibat) and Placebo for PFIC1 and PFIC2. Completed, enrolled 62 participants across 45 sites in 15 countries.

Detailed Summary

Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC) types 1 and 2.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPFIC1, PFIC2
CountriesAustralia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Poland, Saudi Arabia, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 25, 2018
Enrollment StartMay 16, 2018
Primary CompletionJul 27, 2020
Study CompletionJul 28, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.0 years ago

Interventions

A4250 (odevixibat)drug

A4250 is a small molecule and selective inhibitor of ileal bile acid transporter (IBAT).

Placebodrug

Placebo identical in appearance to active drug (A4250).