At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
BMN 165 (rAvPAL-PEG)biological
Likely dose
BMN 165 (rAvPAL-PEG) 2.5mgfrom 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 II, Multi-center, Open-label, Dose-finding Study to Evaluate Safety, Efficacy and Tolerability of Subcutaneously (SC) Administered rAvPAL-PEG in Patients With PKU for 24 Weeks
In Brief
A Phase 2 clinical trial evaluating BMN 165 (rAvPAL-PEG) for Phenylketonuria. Completed, enrolled 24 participants across 6 sites.
Detailed Summary
The primary objective of the study is to evaluate the effect of dosing regimens of multiple subcutaneous (SC) doses of rAvPAL-PEG to induce an early and sustained Phe reduction while decreasing the frequency and severity of hypersensitivity reactions in patients with PKU.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhenylketonuria
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartMay 2012
Primary CompletionSep 2013
Study CompletionJul 2015
TodayJul 2026
First PostedMar 22, 2012
Enrollment StartMay 1, 2012
Primary CompletionSep 1, 2013
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.3 years ago
Interventions
BMN 165 (rAvPAL-PEG)biological
Subcutaneous injection of rAvPAL-PEG administered from 1 time up to 5 times per week between 2.5mg up to a maximum of 375mg for 24 weeks.