deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT03566238

This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2 (PEDFIC 1)

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)

Sponsor: Albireo

Conditions PFIC1 PFIC2
Interventions A4250 (odevixibat) Placebo
Updated 21 times since 2018 Last updated: Nov 17, 2025 Started: May 16, 2018 Primary completion: Jul 27, 2020 Completion: Jul 28, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates PFIC1 and PFIC2 and is currently completed. Albireo leads this study, which shows 21 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Sep 2019 · 3 months · monthly snapshot~Sep 2019 – ~Jan 2020 · 4 months · monthly snapshot~Jan 2020 – ~Apr 2020 · 3 months · monthly snapshot~Apr 2020 – ~Oct 2020 · 6 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Jul 2024 · 33 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – present · 9 months · monthly snapshot

Change History

21 versions recorded

  1. Dec 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Dec 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Oct 2021 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 16 earlier versions

  1. Jan 2021 — Oct 2021 [monthly]

    Completed PHASE3

  2. Oct 2020 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. Apr 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  4. Jan 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  5. Sep 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  6. Jun 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

  7. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  8. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE3

  9. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  10. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

  11. Dec 2018 — Feb 2019 [monthly]

    Recruiting PHASE3

  12. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

  13. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

  14. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

  15. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE3

  16. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE3

    First recorded

May 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Albireo
Data source: Ipsen

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ankara, Turkey (Türkiye) , Antalya, Turkey (Türkiye) , Atlanta, United States , Baltimore, United States , Barcelona, Spain , Bergamo, Italy , Birmingham, United Kingdom , Bron, France , Cleveland, United States , Denver, United States and 33 more locations