A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in China
← catalyst calendarNCT07588880 · readout in 1,715 d
Sponsored by Ipsen (industry) · IPN.PA — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
20estimated
Sites
5
Country
China
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 | 2026-04-16 | actual | When the study began enrolling |
| Primary completion | 2031-04-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-04-30 | estimated | The whole study's end, after follow-up |
| First posted | 2026-05-15 | 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
- Progressive Familial Intrahepatic Cholestasis
Primary outcomes
what the primary-completion date above is the date OFPercentage of participants experiencing adverse events (AEs)
measured From first ICF signature and up to end of data collection (approximately 5 years of data collection), or 30 days after the last dose of odevixibat (in case of treatment discontinuation), whichever comes first.
Percentage of participants experiencing serious adverse events (SAEs)
measured From first ICF signature and up to end of data collection (approximately 5 years of data collection), or 30 days after the last dose of odevixibat (in case of treatment discontinuation), whichever comes first.
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