deltatrials
Completed INTERVENTIONAL NCT03659916

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

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)

Sponsor: Albireo, an Ipsen Company

Interventions A4250 (odevixibat)
Updated 33 times since 2018 Last updated: Apr 29, 2026 Started: Sep 28, 2018 Primary completion: Feb 15, 2024 Completion: Dec 2, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Progressive Familial Intrahepatic Cholestasis and is currently completed. Albireo, an Ipsen Company leads this study, which shows 33 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Jan 2019 · 2 months · monthly snapshot~Jan 2019 – ~Mar 2019 · 59 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~Sep 2019 · 5 months · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Jan 2020 · 2 months · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jun 2022 · 9 months · monthly snapshot~Jun 2022 – ~Nov 2022 · 5 months · monthly snapshot~Nov 2022 – ~Aug 2023 · 9 months · monthly snapshot~Aug 2023 – ~Feb 2024 · 6 months · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Nov 2024 · 31 days · monthly snapshot~Nov 2024 – ~Aug 2025 · 9 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Dec 2025 · 2 months · monthly snapshot~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshot~Mar 2026 – ~May 2026 · 2 months · monthly snapshotMay 4, 2026 – present · 4 months · daily API

Change History

33 versions recorded
  1. May 4, 2026 — Present [daily]

    Completed

    Phase: PHASE3None

  2. Mar 2026 — May 2026 [monthly]

    Completed PHASE3

  3. Feb 2026 — Mar 2026 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  4. Jan 2026 — Feb 2026 [monthly]

    Active Not Recruiting PHASE3

  5. Dec 2025 — Jan 2026 [monthly]

    Active Not Recruiting PHASE3

Show 28 earlier versions
  1. Oct 2025 — Dec 2025 [monthly]

    Active Not Recruiting PHASE3

  2. Sep 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE3

  3. Aug 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Nov 2024 — Aug 2025 [monthly]

    Active Not Recruiting PHASE3

  5. Oct 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE3

  6. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting PHASE3

  7. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  8. Jul 2024 — Aug 2024 [monthly]

    Active Not Recruiting PHASE3

  9. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  10. May 2024 — Jun 2024 [monthly]

    Active Not Recruiting PHASE3

  11. Apr 2024 — May 2024 [monthly]

    Active Not Recruiting PHASE3

  12. Mar 2024 — Apr 2024 [monthly]

    Active Not Recruiting PHASE3

  13. Feb 2024 — Mar 2024 [monthly]

    Active Not Recruiting PHASE3

  14. Aug 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE3

  15. Nov 2022 — Aug 2023 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  16. Jun 2022 — Nov 2022 [monthly]

    Recruiting PHASE3

  17. Sep 2021 — Jun 2022 [monthly]

    Recruiting PHASE3

  18. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  19. Feb 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  20. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  21. Nov 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  22. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  23. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

  24. Apr 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

  25. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

    Status: Enrolling By InvitationRecruiting

  26. Jan 2019 — Mar 2019 [monthly]

    Enrolling By Invitation PHASE3

  27. Nov 2018 — Jan 2019 [monthly]

    Enrolling By Invitation PHASE3

    Status: Not Yet RecruitingEnrolling By Invitation

  28. Oct 2018 — Nov 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Sep 2018

Trial started

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

Eligibility Summary

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

Contact Information

Sponsor contact:
  • Albireo, an Ipsen Company
Data source: ClinicalTrials.gov

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