NCT06305234 A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)
| NCT ID | NCT06305234 |
| Status | Recruiting |
| Phase | — |
| Sponsor | BioMarin Pharmaceutical |
| Condition | Phenylketonuria (PKU) |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-01-20 |
| Primary Completion | 2033-11-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-01-20 with a primary completion date of 2033-11-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a 10-year multi-center, prospective, longitudinal, single arm study evaluating immunologic, inflammatory and laboratory parameters associated with long-term Palynziq treatment in subjects with phenylketonuria (PKU) in the United States (US). Subjects in the US 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 in Study 165-501 (incident-users) or who have previously started treatment with pegvaliase at the date of enrollment in Study 165-501 (prevalent-users) are eligible for participation in Study 165-503.
Eligibility Criteria
Inclusion Criteria: * Subjects enrolled at US sites participating in the 165-501 study. Exclusion Criteria: * Legal incapacity or limited legal capacity without legal guardian representation. * Subject is unable or unwilling to provide informed consent for the additional interventional burden of the study (blood sampling).
Contact & Investigator
Medical Director, MD
STUDY DIRECTOR
BioMarin Pharmaceutical
Frequently Asked Questions
Who can join the NCT06305234 clinical trial?
This trial is open to participants of all sexes, studying Phenylketonuria (PKU). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06305234 currently recruiting?
Yes, NCT06305234 is actively recruiting participants. Contact the research team at medinfo@bmrn.com for enrollment information.
Where is the NCT06305234 trial being conducted?
This trial is being conducted at Aurora, United States, Atlanta, United States, Chicago, United States, Indianapolis, United States and 7 additional locations.
Who is sponsoring the NCT06305234 clinical trial?
NCT06305234 is sponsored by BioMarin Pharmaceutical. The principal investigator is Medical Director, MD at BioMarin Pharmaceutical. The trial plans to enroll 200 participants.