A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace) (NCT05813678)
A Multi-Center, Observational Study to Evaluate the Long-Term Safety of Subcutaneous Injections of Palynziq® (Pegvaliase) in Subjects With Phenylketonuria
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Colorado — Aurora, Colorado
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (26 Sites)
Showing the first 25 of 26 sites.
- University of Colorado — Aurora, Colorado
- Emory University — Atlanta, Georgia
- Northwestern University — Chicago, Illinois
- Indiana University School of Medicine — Indianapolis, Indiana
- Tulane University Medical Center — New Orleans, Louisiana
- Boston Children's Hospital — Boston, Massachusetts
- Oregon Health and Science University — Portland, Oregon
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
- Vanderbilt University Medical School — Nashville, Tennessee
- University of Texas Southwestern Medical Center — Dallas, Texas
- University of Utah — Salt Lake City, Utah
- Medical College of Wisconsin — Milwaukee, Wisconsin
- Hospital Carl-Thiem-Klinikum Cottbus — Cottbus,
- Universitaetsklinikum Hamburg Eppendorf — Hamburg,
- Universitaetslinikum Leipzig AoeR — Leipzig,
- Johannes Gutenberg University of Mainz — Mainz,
- Universitätsklinikum Münster (UKM)-Pädiatrische Universitätsklinik Münster — Münster,
- Universität Ulm — Ulm,
- Policlinico Sant'orsola Malpighi — Bologna,
- University Hospital Careggi — Florence,
- Ospedale San Paolo — Milan,
- Azienda Ospedaliera Universitaria "Federico II" Dipartimento di Pediatria — Naples,
- Azienda Ospedaliera di Padova — Padova,
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone — Palermo,
- Policlinico Gemelli — Rome,
📞 Contact the Study Coordinator
Phone: (800) 983-4587
Email: medinfo@bmrn.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Phenylketonuria (PKU)
- Study to Evaluate the Safety and Efficacy of Pegvaliase in Adolescents (Ages 12-17) With Phenylketonuria — Phoenix, Arizona
- AAV Gene Therapy Study for Subjects with PKU — Tampa, Florida
- A Long-Term Study of JNT-517 in Participants With Phenylketonuria — Gainesville, Florida
- A Study of MZE782 in Adults With PKU — Oakland, California
- A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade) — Aurora, Colorado
Explore by condition: All Phenylketonuria (PKU) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.