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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: Recruiting study of Phenylketonuria, Maternal, sponsored by BioMarin Pharmaceutical.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To estimate the frequency of pregnancy outcomes (eg, spontaneous abortion, stillbirth, live birth, and termination) among subjects with PKU treated with pegvaliase during pregnancy and fetal/infant outcomes (all major congenital malformations \[MCMs\] and specifically microcephaly and congenital heart defects\], FGR, small for gestational age \[SGA\], low birth weight, preterm birth, failure to thrive, and developmental delays) among their offspring exposed to pegvaliase during pregnancy.
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 |
What NCT05579548 shows while recruiting
NCT05579548 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
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 a single indexed study location in 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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