CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 116 enrolled
Drug / intervention
A4250 (odevixibat)drug
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/NCT03659916
NCT03659916Phase 3Completed
CompareCT.gov

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2)

Albireo, an Ipsen Company·interventional·Posted Sep 6, 2018·Updated Apr 30, 2026

In Brief

A Phase 3 clinical trial evaluating A4250 (odevixibat) for Progressive Familial Intrahepatic Cholestasis. Completed, enrolled 116 participants across 41 sites in 15 countries.

Detailed Summary

Open Label Extension Study to evaluate long term safety and persistence of effect of A4250 in children with PFIC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProgressive Familial Intrahepatic Cholestasis
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 PostedSep 6, 2018
Enrollment StartSep 28, 2018
Primary CompletionFeb 15, 2024
Study CompletionDec 2, 2025
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 7.8 years ago

Interventions

A4250 (odevixibat)drug

A4250 is a small molecule and selective inhibitor of IBAT