Fabry Disease Registry - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 22, 2009

Start Date ^ICMJE

April 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00196742 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Fabry Disease Registry

Official Title ^ICMJE

Fabry Disease Registry

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. 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:

To enhance the understanding of the variability, progression, and natural history of Fabry disease, including heterozygous females with the disease;
To assist the Fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care;
To characterize and describe the Fabry population as a whole; and
To evaluate the long-term safety and effectiveness of Fabrazyme®

Detailed Description

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

In Asia-Pacific - Margie Jimenez, +852 2810 1613
In Europe - +31-35-699-1232, europe@FabryRegistry.com
In Latin America - +617-591-5500, help@FabryRegistry.com
In North America - +617-591-5500, help@FabryRegistry.com

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Other

Condition ^ICMJE

Fabry Disease

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00196742

Responsible Party

Medical Monitor, Genzyme Coporation

Study ID Numbers ^ICMJE

Fabry Registry

Study Sponsor ^ICMJE

Genzyme

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Genzyme

Information Provided By

Genzyme

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP