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A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding

Study acronym: PALomino
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Study sites: 3 to 4v6
  3. Re-verified, no change to tracked fieldsv5
  4. Study sites: 1 to 3v4
  5. Start date: Oct 4, 2022 to Nov 22, 2022
    • Secondary endpoints revised (4)
    • Study description expanded, about 14 words
    v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05579548
Lead Sponsor BioMarin Pharmaceutical
Collaborators: Syneos Health
Conditions
(from sponsor)		 Phenylketonuria, Maternal
Related terms Phenylketonuria, Maternal
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov