Condition: Phenylketonuria (PKU) · Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
The goal of this Phase 3, open-label study is to evaluate the long-term safety of JNT-517 in pediatric and adult participants with Phenylketonuria (PKU) after completion of either Study JNT517-101 (NCT05781399) or JNT517-201 (NCT06637514) as well as participants who have not participated in a prior JNT-517 study. In this trial, all participants will receive JNT-517 using age- and weight-banded dosing as outlined in the protocol, regardless of any dose received in a previous study.
This description comes directly from the study's public registry record.
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| University of Florida (UF) Health Shands Hospital | Gainesville, Florida, United States | Recruiting |
| University of South Florida | Tampa, Florida, United States | Recruiting |
| Oregon Health and Science University | Portland, Oregon, United States | Recruiting |
| University of Pittsburgh Medical Center (UPMC) - Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania, United States | Recruiting |
| Children's Medical Center Dallas | Dallas, Texas, United States | Recruiting |
| University of Texas Southwestern Medical Center | Dallas, Texas, United States | Recruiting |
| University of Texas Health (UTHealth) Science Center at Houston | Houston, Texas, United States | Recruiting |
| Utah Health - The University of Utah Hospital | Salt Lake City, Utah, United States | Recruiting |
| Children's Health Queensland - Queensland Children's Hospital | South Brisbane, Queensland, Australia | Recruiting |
| Mater Health - Mater Hospital Brisbane | South Brisbane, Queensland, Australia | Recruiting |
| Royal Adelaide Hospital | Adelaide, South Australia, Australia | Recruiting |
| Murdoch Children's Research Institute | Parkville, Victoria, Australia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06628128