Status:
COMPLETED
Fabry Outcome Survey (FOS)
Lead Sponsor:
Shire
Conditions:
Fabry Disease
Eligibility:
All Genders
Brief Summary
The purpose of this study is to collect data that will increase understanding of Fabry disease history and progression, in treated and untreated patients with Fabry disease. The data from FOS may prov...
Eligibility Criteria
Inclusion
- Participants must have a documented diagnosis of Fabry disease
- This may include a genetic mutation analysis. The collection of the genetic mutation analysis result is optional and dependent on the participant providing their consent for this data to be used in the FOS registry.
- Participants can be untreated, currently or previously treated with Replagal, or any other approved treatment for Fabry disease.
- Signed and dated written informed consent from the participant
- For participants aged less than (\<) 18 years (or as per local regulation), parent and/or participant's legally authorized representative (LAR), and assent of the minor, where applicable, is necessary.
- If a participant is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the informed consent discussion and should sign and personally date the informed consent.
- Informed consent must be obtained from LARs for cognitively impaired participants when applicable.
Exclusion
- 1\. Participants currently enrolled in ongoing blinded clinical trials (drugs or devices; includes all blinded trials) will be excluded from the Registry.
Key Trial Info
Start Date :
April 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT03289065
Start Date
April 1 2001
End Date
September 30 2021
Last Update
November 16 2021
Active Locations (1)
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1
Shire
Lexington, Massachusetts, United States, 02421