Fabry Disease Registry

This study is currently recruiting patients.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00196742

Purpose

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. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient’s treating physician.

The objectives of the Registry are:

Condition

Fabry Disease

Study Type: Observational

Study Design: Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study

Further Study Details:
Study Start: 1991-04

The Fabry Registry is an international program; in addition to the central contact information provided under the “Location” heading, patients may contact:

Eligibility Criteria

Ages Eligible for Study: Both

Inclusion Criteria:
All patients with a confirmed diagnosis of Fabry disease are eligible for inclusion in the Registry. Confirmed diagnosis is defined as:
-a documented plasma or leukocyte α-galactosidase A (α-gal A) deficiency, or
-a documented α-gal A deficiency and/or mutation in the α-gal A gene in heterozygous females.

For all patients, appropriate patient authorization will be obtained.

Exclusion Criteria:
There are no exclusion criteria for participation in the Fabry Registry. Registry participation does not exclude participation in other clinical studies.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00196742

Central Contact: Fabry Registry HelpLine 800-745-4447, Ext. 15500 help@fabryregistry.com Fabry Registry HelpLine 617-591-5500 help@fabryregistry.com

Registry participation is worldwide and not limited by facility; facilities not yet active may enroll upon identification of a patient.

More Information

Study ID Numbers: Fabry Registry
ClinicalTrials.gov Identifier: NCT00196742
Health Authority: United States: Institutional Review Board