A study to monitor safety of Velaglucerase alfa in India
Phase 4
- Conditions
- Health Condition 1: E752- Other sphingolipidosis
- Registration Number
- CTRI/2021/07/034906
- Lead Sponsor
- Shire Human Genetic Therapies Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with Gaucher disease prescribed VPRIV according to the investigators judgment and current Indian PI are eligible for this study. Patient or legally authorized representative must provide written informed consent to participate
Exclusion Criteria
Patients will be excluded from this study if the patient met any of the contraindications included
in the current Indian PI for VPRIV
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterize the safety profile of VPRIV using both retrospective and prospective data, when used as standard clinical practice for patients with Gaucher disease in India.Timepoint: 12 months (Throughout the study)
- Secondary Outcome Measures
Name Time Method To collect and record genetic mutation data, if available, from patients with Gaucher diseaseTimepoint: 12 Months (Throughout the study);To collect retrospective data on treatment history, effectiveness, and safety data of the previous VPRIV treatmentTimepoint: 12 Months (Throughout the study);To describe effectiveness in patients with Gaucher disease receiving VPRIV using both retrospective and prospective data, when used in standard clinical practice in IndiaTimepoint: 12 Months (Throughout the study)