At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 37 enrolled
Drug / intervention
Pegvaliasedrug
Likely dose
Pegvaliase 60mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Injections of Pegvaliase (> 40 mg/Day Dose) in Adults With Phenylketonuria
In Brief
A Phase 3 clinical trial evaluating Pegvaliase for Phenylketonuria (PKU). Completed, enrolled 37 participants across 17 sites.
Detailed Summary
This is a Phase 3 open-label extension study enrolling adult patients with PKU who were previously treated with pegvaliase in Studies PAL-003 (NCT00924703) or 165-302 (NCT02468570). The study is designed to evaluate the long-term safety and efficacy of pegvaliase administered at doses \> 40 mg/day to 60 mg/day.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhenylketonuria (PKU)
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartSep 2018
First PostedOct 2018
Primary CompletionJan 2021
TodayJul 2026
First PostedOct 3, 2018
Enrollment StartSep 13, 2018
Primary CompletionJan 13, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.7 years ago
Interventions
Pegvaliasedrug
40-60mg/day