Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-28

Study Completion Date

2023-04-22

Brief Summary

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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-marketing setting and to collect genetic mutation data from participants with Gaucher disease.

This study is about collecting data available in the participant's medical record as well as data from each participant's ongoing treatment. No study medicines will be provided to participants in this study.

When the participants start the study, they will visit the study clinic close to approximately 12 months.

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Detailed Description

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Conditions

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Gaucher Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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VPRIV: All Participants

Participants with type 1 Gaucher disease who as part of standard or routine clinical practice, have already received VPRIV retrospectively and will further receive VPRIV therapy according to the investigator's judgment for approximately 12 months will be observed prospectively in this PMS study.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.