CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
Velaglucerase alfa +1 moredrug
Likely dose
Not stated in 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/NCT02574286
NCT02574286Phase 4Completed
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An Open-label, Multicenter, Single-arm, Phase 4 Study of the Effect of Treatment With Velaglucerase Alfa on Bone-related Pathology in Treatment-naïve Patients With Type 1 Gaucher Disease

Shire·interventional·Posted Oct 12, 2015·Updated Feb 1, 2022

In Brief

A Phase 4 clinical trial evaluating Velaglucerase alfa and Vitamin D for Gaucher Disease. Completed, enrolled 21 participants across 15 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGaucher Disease
CountriesIsrael, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 12, 2015
Enrollment StartJun 29, 2016
Primary CompletionNov 12, 2020
Study CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 10.7 years ago

Interventions

Velaglucerase alfadrug

Participants will receive 60-minute intravenous infusion of 60 U/kg velaglucerase alfa EOW.

Vitamin Ddietary

Participants will receive 800 IU vitamin D orally daily.