Status:
COMPLETED
Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India
Lead Sponsor:
Shire
Conditions:
Gaucher Disease
Eligibility:
All Genders
Brief Summary
The main aim of this study is to measure the safety and to find out the effects of VPRIV in participants with Gaucher disease using both retrospective and prospective data when used in the post-market...
Eligibility Criteria
Inclusion
- Participants with type 1 Gaucher disease prescribed VPRIV according to the investigator's judgment and current Indian Prescribing information (PI) are eligible for this study.
- Participants or legally authorized representative must provide written informed consent to participate.
Exclusion
- \- Participants will be excluded from this study if the participant met any of the contraindications included in the current Indian PI for VPRIV.
Key Trial Info
Start Date :
July 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 22 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04429984
Start Date
July 28 2021
End Date
April 22 2023
Last Update
June 7 2023
Active Locations (2)
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1
Amrita Institute of Medical Sciences & Research Centre (AIMS)
Kochi, Kerala, India, 682041
2
All India Institute of Medical Sciences
New Delhi, India, 110029