CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
rAvPAL-PEG 0.001 mg/kg +4 moredrug
Likely dose
rAvPAL-PEG 0.001 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.

Search/NCT00925054
NCT00925054Phase 2Completed
CompareCT.gov

Phase 2, Open-Label Dose-Finding Study to Evaluate the Safety, Efficacy, and Tolerability of Multiple Subcutaneous (SC) Doses of rAvPAL-PEG in Subjects With PKU

BioMarin Pharmaceutical·interventional·Posted Jun 19, 2009·Updated Feb 26, 2019

In Brief

A Phase 2 clinical trial evaluating rAvPAL-PEG 0.001 mg/kg, rAvPAL-PEG 0.003 mg/kg, and 3 other interventions for Phenylketonuria. Completed, enrolled 40 participants across 11 sites.

Detailed Summary

The purpose of this study is to evaluate whether weekly injections of phenylalanine ammonia lyase (rAvPAL-PEG) can reduce blood phenylalanine concentrations in PKU subjects and whether repeated administration is safe.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhenylketonuria
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 19, 2009
Enrollment StartSep 1, 2009
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 17.0 years ago

Interventions

rAvPAL-PEG 0.001 mg/kgdrug

In Part 1, the planned starting dose levels is 0.001 mg/kg

rAvPAL-PEG 0.003 mg/kgdrug

In Part 1, the planned starting dose levels is 0.003 mg/kg

rAvPAL-PEG 0.01 mg/kgdrug

In Part 1, the planned starting dose levels is 0.01 mg/kg

rAvPAL-PEG 0.03 mg/kgdrug

In Part 1, the planned starting dose levels is 0.03 mg/kg

rAvPAL-PEG 0.1 mg/kgdrug

In Part 1, the planned starting dose levels is 0.1 mg/kg