Health Condition 1: E752- Other sphingolipidosis
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Shire Human Genetic Therapies Inc
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
India
Contacts
Public ContactRuchi Sogarwal
Shire Biotech India Private Limited
Outcome results
None listed