drugset / Trial / NCT02574286

Study of the Effect of Velaglucerase Alfa (VPRIV®) on Bone-related Pathology in Treatment-naïve Participants With Type 1 Gaucher Disease

NCT02574286

Phase 4 Completed 21 enrolled Shire
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

EvaluationDrugModalityDoseRoute
Subject velaglucerase alfa Protein / enzyme biologic 60 iu/kg Intravenous

Indications