A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding
← catalyst calendarNCT05579548 · readout in 2,238 d
Sponsored by BioMarin Pharmaceutical (industry) · BMRN — their whole pipeline →. With Syneos Health.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
50estimated
Sites
4
Countries
Canada, Germany, Italy +1
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 | 2022-11-22 | actual | When the study began enrolling |
| Primary completion | 2032-10-04 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2032-10-04 | estimated | The whole study's end, after follow-up |
| First posted | 2022-10-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Phenylketonuria, Maternal
Intervention
- Drug: Pegvaliase
Primary outcome
what the primary-completion date above is the date OFPregnancy outcome and infant development for women who have been treated with Palynziq (pegvaliase) within 2 weeks of their last menstrual period
measured 10 years
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