Fabry Outcome Survey (FOS)

Launched by SHIRE · Sep 18, 2017

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. 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 Criteria:
• • 1. Participants currently enrolled in ongoing blinded clinical trials (drugs or devices; includes all blinded trials) will be excluded from the Registry.