At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 16 enrolled
Drug / intervention
rAvPAL-PEGdrug
Likely dose
rAvPAL-PEG 0.06 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.
A Phase 2, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Dose Levels of rAvPAL-PEG Administered Daily in Subjects With Phenylketonuria
In Brief
A Phase 2 clinical trial evaluating rAvPAL-PEG for Phenylketonuria. Completed, enrolled 16 participants across 9 sites.
Detailed Summary
The purpose of this study is to evaluate the effect of daily administration of rAvPAL-PEG on the reduction of blood Phe concentrations in subjects with PKU.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhenylketonuria
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartMar 2011
Primary CompletionApr 2015
TodayJul 2026
First PostedOct 1, 2010
Enrollment StartMar 1, 2011
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 15.8 years ago
Interventions
rAvPAL-PEGdrug
0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day