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NCT05579548 · ClinicalTrials.gov registry record
A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding
A clinical trial of Phenylketonuria, Maternal, sponsored by BioMarin Pharmaceutical.
- Recruiting
- Registry status
- 50
- Enrollment target
- 4
- Study locations
NCT05579548 is a study of Phenylketonuria, Maternal that is actively recruiting participants, run by BioMarin Pharmaceutical. The registered enrollment target is 50 participants. The trial reports 4 study locations across 2 states.
The verdict
NCT05579548, a study of Phenylketonuria, Maternal, is actively recruiting participants, sponsored by BioMarin Pharmaceutical.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a Phase 4 observational study designed to assess the impact of Palynziq ® (pegvaliase) treatment in pregnant women with PKU and on their offspring who were exposed to pegvaliase at any time during pregnancy and breastfeeding.
Conditions Studied
Interventions
- DRUG Pegvaliase
Study Locations (4)
Other
- Metabolics and Genetics in Calgary (MAGIC) - Calgary
- Universitaetsklinikum Hamburg Eppendorf - Hamburg
- Ospedale San Paolo - Milan
North Carolina
- Syneos Health - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-11-22 |
| Est. Completion | 2032-10-04 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05579548
The ClinicalTrials.gov registry entry for NCT05579548 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Phenylketonuria, Maternal appearing as the primary indexed condition, and to 1 intervention - of which Pegvaliase is the first listed.
NCT05579548 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Other, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05579548 about?
NCT05579548 is a clinical study titled "A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding". This is a Phase 4 observational study designed to assess the impact of Palynziq ® (pegvaliase) treatment in pregnant women with PKU and on their offspring who were exposed to pegvaliase at any time during pregnancy and breastfeeding.
What is the current status of trial NCT05579548?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2022-11-22. Estimated completion is 2032-10-04.
What conditions does trial NCT05579548 study?
This clinical trial studies the following conditions: Phenylketonuria, Maternal.
What interventions are being tested in trial NCT05579548?
The interventions under investigation include: Pegvaliase (DRUG).
Who is sponsoring clinical trial NCT05579548?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05579548 being conducted?
This trial has 4 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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