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A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace)

Study acronym: PALace
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Study sites: 16 to 26v5
  2. Study sites: 10 to 16
    • Secondary endpoints: details revised at 1 of 1 entry
    v4
  3. Study sites: 5 to 10v3
  4. Primary endpoint revised
    • Secondary endpoint revised
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 10-year multi-center, global, observational study to further characterize the safety profile of pegvaliase, including hypersensitivity reactions, long-term safety and tolerability, and the effectiveness of the additional risk minimization measures (aRMMs) (European Union (EU) only) in subjects receiving pegvaliase for the treatment of PKU. Subjects for whom a clinical decision has been made that they will receive pegvaliase to treat their PKU within 30 days following the date of enrollment (incident-users) or have previously started treatment with pegvaliase at the date of enrollment (prevalent-users) are eligible for participation in this study.
Trial Details
NCT Number NCT05813678
Lead Sponsor BioMarin Pharmaceutical
Conditions
(from sponsor)		 Phenylketonuria (PKU)
Related terms Phenylketonurias
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov