Status:
COMPLETED
Long Term Impact of Rapid Intravenous Infusion of Velaglucerase Alfa (VPRIV)
Lead Sponsor:
Shaare Zedek Medical Center
Collaborating Sponsors:
Shire
Conditions:
Gaucher Disease, Type 1
Eligibility:
All Genders
6-75 years
Phase:
PHASE4
Brief Summary
Background: In order to allow our satisfied patients, who have successfully completed 24 months of rapid intravenous infusion of Velaglucerase alfa (VPRIV), to continue with the 10 minutes IV therapy,...
Detailed Description
Every 6 months, patients will be required to come for routine checkups at SZMC, where the following tests will be performed: * Complete Blood Count (CBC) * Routine serum biochemistry including liver ...
Eligibility Criteria
Inclusion
- Aged 18-75 years, non-splenectomized Enzymatic diagnosis \& molecular analysis indicative of type 1 Gaucher disease Receiving VPRIV for at least 6 infusions (3 months) prior to Baseline at a constant dose and frequency and without clinically significant AEs including allergic reactions
Exclusion
- Experience of a clinically significant AE to VPRIV at any time in the past Existence of a clinically significant co-morbidity
Key Trial Info
Start Date :
January 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04120506
Start Date
January 10 2016
End Date
January 1 2022
Last Update
October 28 2022
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