A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS). (RISE)
Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome
Sponsor: Mirum Pharmaceuticals, Inc.
Listed as NCT04729751, this PHASE2 trial focuses on Alagille Syndrome and Cholestatic Liver Disease and remains completed. Sponsored by Mirum Pharmaceuticals, Inc., it has been updated 19 times since 2021, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
19 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE2
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Mar 2025 — Sep 2025 [monthly]
Completed PHASE2
Status: Active Not Recruiting → Completed
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Sep 2024 — Mar 2025 [monthly]
Active Not Recruiting PHASE2
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE2
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Apr 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE2
▶ Show 14 earlier versions
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Oct 2023 — Apr 2024 [monthly]
Active Not Recruiting PHASE2
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Jun 2023 — Oct 2023 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Apr 2023 — Jun 2023 [monthly]
Recruiting PHASE2
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Mar 2023 — Apr 2023 [monthly]
Recruiting PHASE2
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Sep 2022 — Mar 2023 [monthly]
Recruiting PHASE2
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Jul 2022 — Sep 2022 [monthly]
Recruiting PHASE2
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Jun 2022 — Jul 2022 [monthly]
Recruiting PHASE2
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May 2022 — Jun 2022 [monthly]
Recruiting PHASE2
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Jan 2022 — May 2022 [monthly]
Recruiting PHASE2
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Nov 2021 — Jan 2022 [monthly]
Recruiting PHASE2
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Oct 2021 — Nov 2021 [monthly]
Recruiting PHASE2
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Sep 2021 — Oct 2021 [monthly]
Recruiting PHASE2
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Jun 2021 — Sep 2021 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Feb 2021 — Jun 2021 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Mirum Pharmaceuticals, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .