At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 68 enrolled
Drug / intervention
rAvPAL-PEGdrug
Likely dose
rAvPAL-PEG 5.0 mg/kgfrom 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.
Long-term Extension of a Phase 2, Open-Label Dose-Finding Study to Evaluate the Safety, Efficacy, and Tolerability of Multiple Subcutaneous Doses of rAvPAL-PEG in Subjects With PKU
In Brief
A Phase 2 clinical trial evaluating rAvPAL-PEG for Phenylketonuria. Completed, enrolled 68 participants across 14 sites.
Detailed Summary
This study is an extension of previous rAvPAL-PEG studies. Administration of rAvPAL-PEG will be continued to assess whether long-term dosing of rAvPAL-PEG is safe and can maintain reduced blood Phe concentrations in PKU subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhenylketonuria
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartJan 2010
Primary CompletionJan 2019
TodayJul 2026
First PostedJun 19, 2009
Enrollment StartJan 13, 2010
Primary CompletionJan 31, 2019
TodayJul 2, 2026
Enrollment to primary: 9.0 yearsPosted 17.0 years ago
Interventions
rAvPAL-PEGdrug
The doses are planned to be in the same range as those tested in PAL-002 or PAL-004 and then modified either by increasing or decreasing the dose, adhering to an upper limit up to 5.0 mg/kg per week or 375 mg/week, considering each subject's individual responses related to safety and efficacy.