drugset / Trial / NCT02574286
Study of the Effect of Velaglucerase Alfa (VPRIV®) on Bone-related Pathology in Treatment-naïve Participants With Type 1 Gaucher Disease
NaSingle-groupOpen-labelTreatment
Summary
The primary purpose of this study is to evaluate the effect of VPRIV therapy (60 units per kilogram \[U/kg\] every other week \[EOW\]) in treatment-naive participants with type 1 Gaucher disease on change from baseline in lumbar spine (LS) bone mineral density (BMD) Z-score as measured by dual energy x-ray absorptiometry (DXA) after 24 months of treatment.
Timeline
- Start
- 2016-06-29
- Primary completion
- 2020-11-12
- Completion
- 2020-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | velaglucerase alfa | Protein / enzyme biologic | 60 iu/kg | Intravenous |