A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)
Public ClinicalTrials.gov record NCT06305234. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-Center, Prospective, Longitudinal, Study Evaluating Immunologic, Inflammatory, and Laboratory Parameters Associated With Long-Term Palynziq® (Pegvaliase) Treatment in Subjects With Phenylketonuria (PKU) in the United States
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06305234
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 19, 2024
- Primary completion
- Nov 17, 2033
- Completion
- Nov 17, 2033
- Last update posted
- Mar 23, 2026
2024 – 2033
United States locations
- U.S. sites
- 11
- U.S. states
- 11
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | Recruiting |
| Emory University | Atlanta | Georgia | 30322 | Recruiting |
| Northwestern University | Chicago | Illinois | 60611 | Recruiting |
| Riley Children's Hospital/ Indiana University Health | Indianapolis | Indiana | 46202 | Recruiting |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | Recruiting |
| Boston Children's Hospital | Boston | Massachusetts | 02215 | Recruiting |
| Oregon Health & Science University | Portland | Oregon | 97239 | Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| Vanderbilt University Medical School | Nashville | Tennessee | 37235 | Recruiting |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| Children's Wisconsin/Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06305234, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 23, 2026 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06305234 live on ClinicalTrials.gov.