An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
← catalyst calendarSponsored by Mirum Pharmaceuticals, Inc. (industry) · MIRM — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
84actual
Sites
28
Countries
Argentina, Austria, Belgium +13
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-01-08 | actual | When the study began enrolling |
| Primary completion | 2025-04-23 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-23 | actual | The whole study's end, after follow-up |
| First posted | 2019-12-04 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-23 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Progressive Familial Intrahepatic Cholestasis (PFIC)
Intervention
- Drug: Maralixibat
Primary outcome
what the primary-completion date above is the date OFMean Change From Baseline Over Time in the Average Morning ItchRO(Obs) Severity Score
measured From Baseline to Weeks 75-78
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2021-11-18 · 2.5 MB · Prot_000.pdf
Statistical Analysis Planposted 2022-10-12 · 4.8 MB · SAP_001.pdf
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