Actively Recruiting
A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace)
Led by BioMarin Pharmaceutical · Updated on 2026-03-25
450
Participants Needed
26
Research Sites
595 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of PKU per local standard of care
- Currently receiving or planned to receive pegvaliase treatment within 30 days after enrollment
- Willing and able to provide written informed consent before any data collection
You will not qualify if you...
- Any disorder that may prevent giving informed consent or complying with the study
- Currently participating in an interventional study with any investigational product, device, or procedure
- Previously enrolled in this study and withdrawn, wishing to rejoin later
- German subjects younger than 16 years of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
Tulane University Medical Center
New Orleans, Louisiana, United States, 70118
Actively Recruiting
6
Boston Children's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
8
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
9
Vanderbilt University Medical School
Nashville, Tennessee, United States, 37235
Actively Recruiting
10
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
11
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
12
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
13
Hospital Carl-Thiem-Klinikum Cottbus
Cottbus, Germany
Actively Recruiting
14
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany
Actively Recruiting
15
Universitaetslinikum Leipzig AoeR
Leipzig, Germany
Actively Recruiting
16
Johannes Gutenberg University of Mainz
Mainz, Germany
Actively Recruiting
17
Universitätsklinikum Münster (UKM)-Pädiatrische Universitätsklinik Münster
Münster, Germany
Actively Recruiting
18
Universität Ulm
Ulm, Germany
Actively Recruiting
19
Policlinico Sant'orsola Malpighi
Bologna, Italy
Actively Recruiting
20
University Hospital Careggi
Florence, Italy
Actively Recruiting
21
Ospedale San Paolo
Milan, Italy
Actively Recruiting
22
Azienda Ospedaliera Universitaria "Federico II" Dipartimento di Pediatria
Naples, Italy
Actively Recruiting
23
Azienda Ospedaliera di Padova
Padova, Italy
Actively Recruiting
24
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Actively Recruiting
25
Policlinico Gemelli
Rome, Italy
Actively Recruiting
26
Sapienza University of Rome Hospital
Rome, Italy
Actively Recruiting
Research Team
1
165-501 Program Director
CONTACT
M
Medical Director, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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