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Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC

NCT03659916 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-04-30

Study results available
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Summary

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

Conditions

  • Progressive Familial Intrahepatic Cholestasis

Interventions

DRUG

A4250 (odevixibat)

A4250 is a small molecule and selective inhibitor of IBAT

Sponsors & Collaborators

  • Albireo, an Ipsen Company

    lead INDUSTRY

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Months
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-28
Primary Completion
2024-02-15
Completion
2025-12-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Saudi Arabia
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

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 NCT03659916 on ClinicalTrials.gov