Status:
RECRUITING
Fabry Disease Registry & Pregnancy Sub-registry
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Fabry Disease
Eligibility:
All Genders
Brief Summary
The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Fabry Registry: All patients with a confirmed diagnosis of Fabry disease who have signed the informed consent and patient authorization form(s) are eligible for inclusion. Confirmed diagnosis is defined as a documented deficiency in plasma or leukocyte αGAL (alpha-galactosidase) enzyme activity and/or mutation(s) in the gene coding for αGAL.
- Fabry Pregnancy Sub-registry:
- Eligible women must:
- be enrolled in the Fabry Registry.
- be pregnant, or have been pregnant with appropriate medical documentation available.
- provide a signed informed consent and authorization form(s) to participate in the Sub-Registry prior to any Sub-Registry-related data collection being performed.
- Exclusion Criteria Fabry Registry: There are no exclusion criteria. Fabry Pregnancy Sub-registry: There are no exclusion criteria.
Exclusion
Key Trial Info
Start Date :
July 31 2001
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2034
Estimated Enrollment :
9000 Patients enrolled
Trial Details
Trial ID
NCT00196742
Start Date
July 31 2001
End Date
January 31 2034
Last Update
December 31 2025
Active Locations (281)
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1
University of Alabama Birmingham- Nephrology- Site Number : 840018
Birmingham, Alabama, United States, 35294
2
University of Alabama Birmingham- Nephrology- Site Number : 840073
Birmingham, Alabama, United States, 35294
3
Phoenix Children's Hospital- Site Number : 840003
Phoenix, Arizona, United States, 85013
4
University of Arizona- Site Number : 840015
Tucson, Arizona, United States, 85724