Odevixibat Outcomes in Patients With PFIC Versus an External Control Cohort (OvEC-PFIC)
← catalyst calendarSponsored by Ipsen (industry) · IPN.PA — their whole pipeline →. With Erasmus Medical Center, University Medical Center Groningen.
Phase
—
Status
Active, not recruiting
Study type
Observational
Enrollment
200estimated
Sites
1
Country
France
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 | 2026-04-26 | actual | When the study began enrolling |
| Primary completion | 2026-08-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-09-30 | estimated | The whole study's end, after follow-up |
| First posted | 2026-03-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- PFIC - Progressive Familial Intrahepatic Cholestasis
Primary outcomes
what the primary-completion date above is the date OFPart A: Liver transplant-free survival (LTFS)
measured From the date of first odevixibat treatment or from the date of first registry entry into NAPPED group where OvEC cohort eligibility criteria were met, until the first occurrence of the defined event or last available follow-up (2017-2025)
Part B: Liver transplant-free survival (LTFS)
measured From the date of first odevixibat treatment (Odevixibat Cohort) or from the from the date of SBD (External control cohort) until the first occurrence of the defined event or last available follow-up (2017-2025)
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