A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace)
Public ClinicalTrials.gov record NCT05813678. 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, Observational Study to Evaluate the Long-Term Safety of Subcutaneous Injections of Palynziq® (Pegvaliase) in Subjects With Phenylketonuria
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05813678
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 450 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
- Jun 5, 2022
- Primary completion
- Oct 31, 2033
- Completion
- Oct 31, 2033
- Last update posted
- Mar 24, 2026
2022 – 2033
United States locations
- U.S. sites
- 12
- U.S. states
- 12
- U.S. cities
- 12
| 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 |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | Recruiting |
| Tulane University Medical Center | New Orleans | Louisiana | 70118 | Recruiting |
| Boston Children's Hospital | Boston | Massachusetts | 02215 | Recruiting |
| Oregon Health and Science University | Portland | Oregon | 97239 | Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | Recruiting |
| Vanderbilt University Medical School | Nashville | Tennessee | 37235 | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| University of Utah | Salt Lake City | Utah | 84112 | Recruiting |
| 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
Recently updated Phenylketonuria (PKU) trials
Other public records listing Phenylketonuria (PKU). Sorted by last update posted; newest first. Not a recommendation.
- NCT05270837: Study to Evaluate the Safety and Efficacy of Pegvaliase in Adolescents (Ages 12-17) With Phenylketonuria Active, not recruiting
- NCT07694440: A Study of MZE782 in Adults With PKU Recruiting
- NCT06628128: A Long-Term Study of JNT-517 in Participants With Phenylketonuria Recruiting
- NCT06305234: A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade) Recruiting
- NCT04480567: AAV Gene Therapy Study for Subjects with PKU Active, not recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05813678, 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 24, 2026 · Synced Aug 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05813678 live on ClinicalTrials.gov.