deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT04185363

An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)

An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Maralixibat in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)

Sponsor: Mirum Pharmaceuticals, Inc.

Interventions Maralixibat
Updated 17 times since 2020 Last updated: Jun 25, 2025 Started: Jan 8, 2020 Primary completion: Apr 23, 2025 Completion: Apr 23, 2025
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 Progressive Familial Intrahepatic Cholestasis (PFIC) and is currently completed. Mirum Pharmaceuticals, Inc. leads this study, which shows 17 recorded versions since 2020 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Jul 2020 · 5 months · monthly snapshot~Jul 2020 – ~Oct 2020 · 3 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Jan 2022 · 10 months · monthly snapshot~Jan 2022 – ~Jul 2022 · 6 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2023 · 14 months · monthly snapshot~Nov 2023 – ~Jun 2024 · 7 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Mar 2025 · 4 months · monthly snapshot~Mar 2025 – ~Jul 2025 · 4 months · monthly snapshot~Jul 2025 – ~Sep 2025 · 2 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

17 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Jul 2025 — Sep 2025 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  3. Mar 2025 — Jul 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Nov 2024 — Mar 2025 [monthly]

    Active Not Recruiting PHASE3

  5. Sep 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE3

Show 12 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  2. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

  3. Nov 2023 — Jun 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: Enrolling By InvitationActive Not Recruiting

  4. Sep 2022 — Nov 2023 [monthly]

    Enrolling By Invitation PHASE3

  5. Jul 2022 — Sep 2022 [monthly]

    Enrolling By Invitation PHASE3

  6. Jan 2022 — Jul 2022 [monthly]

    Enrolling By Invitation PHASE3

  7. Mar 2021 — Jan 2022 [monthly]

    Enrolling By Invitation PHASE3

  8. Jan 2021 — Mar 2021 [monthly]

    Enrolling By Invitation PHASE3

  9. Oct 2020 — Jan 2021 [monthly]

    Enrolling By Invitation PHASE3

  10. Jul 2020 — Oct 2020 [monthly]

    Enrolling By Invitation PHASE3

  11. Feb 2020 — Jul 2020 [monthly]

    Enrolling By Invitation PHASE3

    Status: Not Yet RecruitingEnrolling By Invitation

  12. Jan 2020 — Feb 2020 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Mirum Pharmaceuticals, Inc.
Data source: Mirum Pharmaceuticals, Inc.

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