A Study of VPRIV in Participants With Gaucher Disease Previously Treated With Other Enzyme Replacement Therapies or Substrate Reduction Therapies
NCT ID: NCT04094181
Last Updated: 2024-02-02
Study Results
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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TERMINATED
2 participants
OBSERVATIONAL
2019-09-19
2021-11-17
Brief Summary
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In this study, data on VPRIV will be collected from the medical records of participants who already transitioned to VPRIV before this study started. Other participants will join this study when they transition to VPRIV. All participants will be followed to allow for 12 months of observation from time of transition to VPRIV.
The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
OTHER
Study Groups
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VPRIV Participants
Participants who has been transitioned from ERTs/SRTs to VPRIV, the data will be collected retrospectively from time of transition until the point at which participant begins in this study and then will be followed up prospectively for 12 months.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participant or legally authorized representative has provided written informed consent.
Exclusion Criteria
* In the opinion of the investigator, participant is unsuitable in any other way to participate in this study.
* Participant is pregnant.
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Shire
Locations
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University of Alberta/Medical Genetics Clinic
Edmonton, Alberta, Canada
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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EUPAS42338
Identifier Type: REGISTRY
Identifier Source: secondary_id
SHP669-405
Identifier Type: -
Identifier Source: org_study_id
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