drugset / Trial / NCT01560286
A Study to Evaluate Subcutaneously Administered rAvPAL-PEG in Patients With Phenylketonuria for 24 Weeks
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2012-05
- Primary completion
- 2013-09
- Completion
- 2015-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegvaliase | Protein / enzyme biologic | 2.5 mg | Subcutaneous |
| Subject | Pegvaliase | Protein / enzyme biologic | 375 mg | Subcutaneous |