At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 20 enrolled
Drug / intervention
Velaglucerase Alfadrug
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.
A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Velaglucerase Alfa in Chinese Subjects With Type 1 Gaucher Disease
In Brief
A Phase 3 clinical trial evaluating Velaglucerase Alfa for Gaucher Disease. Completed, enrolled 20 participants across 10 sites.
Detailed Summary
The main purpose of this study is to observe the side effects of VPRIV in participants with type 1 Gaucher disease who are either treatment-naïve (newly diagnosed) or who are currently being treated with enzyme replacement therapy (ERT). Participants will receive VPRIV intravenously during the treatment period (up to 51 weeks), followed by the end-of-treatment (EOT) visit after 2 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGaucher Disease
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedSep 2022
Enrollment StartJan 2023
Primary CompletionAug 2024
TodayJul 2026
First PostedSep 7, 2022
Enrollment StartJan 3, 2023
Primary CompletionAug 5, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 3.8 years ago
Interventions
Velaglucerase Alfadrug
VPRIV intravenous infusion every other week for 60 minutes.