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: - 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®

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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.

Exclusion Criteria

There are no exclusion criteria in this Registry. Patients are allowed to participate in other clinical studies and may be receiving different therapies to treat their disease; however, enrollment in other clinical studies should be noted on the Registry case report forms (CRFs).

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Recruiting Locations

Investigational Site Number 840018
Birmingham, Alabama 35294

Investigational Site Number 840073
Birmingham, Alabama 35294

Investigational Site Number 840109
Little Rock, Arkansas 72202

Investigational Site Number 840113
Little Rock, Arkansas 72205

Investigational Site Number 840108
Los Angeles, California 90027

Investigational Site Number 840042
Sacramento, California 95825

Investigational Site Number 840047
New Haven, Connecticut 06520

Investigational Site Number 840067
Washington, District of Columbia 20010

Investigational Site Number 840075
Coral Springs, Florida 33065

Investigational Site Number 840083
Gainesville, Florida 32610

Investigational Site Number 840112
Jacksonville, Florida 32216

Investigational Site Number 840096
Tampa, Florida 33606

Investigational Site Number 840060
Decatur, Georgia 30033

Investigational Site Number 840013
Chicago, Illinois 60611

Investigational Site Number 840079
Chicago, Illinois 60612

Investigational Site Number 840027
Indianapolis, Indiana 46202

Investigational Site Number 840032
Iowa City, Iowa 52242

Investigational Site Number 840071
Kansas City, Kansas 66160

Investigational Site Number 840030
Louisville, Kentucky 40202

Investigational Site Number 840001
New Orleans, Louisiana 70112

Investigational Site Number 840064
Portland, Maine 04102

Investigational Site Number 840044
Baltimore, Maryland

Investigational Site Number 840062
Boston, Massachusetts 02114

Investigational Site Number 840092
Boston, Massachusetts 02115

Investigational Site Number 840103
Boston, Massachusetts 02115

Investigational Site Number 840002
Springfield, Massachusetts 01199

Investigational Site Number 840107
Ann Arbor, Michigan 48109

Investigational Site Number 840050
Grand Rapids, Michigan 49525

Investigational Site Number 840046
Minneapolis, Minnesota 55404

Investigational Site Number 840031
Columibia, Missouri 65212

Investigational Site Number 840100
Saint Louis, Missouri 63110

Investigational Site Number 840090
Helena, Montana 59601

Investigational Site Number 840084
Omaha, Nebraska 68198

Investigational Site Number 840098
Camden, New Jersey

Investigational Site Number 840101
Hackensack, New Jersey 07601

Investigational Site Number 840099
Morristown, New Jersey 07960

Investigational Site Number 840016
New Brunswick, New Jersey 08901

Investigational Site Number 840057
Paterson, New Jersey 07503

Investigational Site Number 840102
Manhasset, New York 11030

Investigational Site Number 840040
New York, New York 10016

Investigational Site Number 840080
New York, New York 10029

Investigational Site Number 840110
New York, New York 10029

Investigational Site Number 840105
Rochester, New York 14642

Investigational Site Number 840052
Syracuse, New York 13210

Investigational Site Number 840039
Valhalla, New York 10595

Investigational Site Number 840065
Charlotte, North Carolina 28232

Investigational Site Number 840045
Durham, North Carolina 27710

Investigational Site Number 840033
Cincinnati, Ohio

Investigational Site Number 840048
Cleveland, Ohio 44195

Investigational Site Number 840097
Columbus, Ohio 43210

Investigational Site Number 840094
Dublin, Ohio 43017

Investigational Site Number 840111
Danville, Pennsylvania 17822

Investigational Site Number 840104
Hershey, Pennsylvania 17033

Investigational Site Number 840089
Philadelphia, Pennsylvania 19104

Investigational Site Number 840034
Philadelphia, Pennsylvania

Investigational Site Number 840023
Pittsburgh, Pennsylvania 15224

Investigational Site Number 840053
Providence, Rhode Island 02903

Investigational Site Number 840055
Greenville, South Carolina 29605

Investigational Site Number 840049
Nashville, Tennessee 38232

Investigational Site Number 840058
Dallas, Texas 75226

Investigational Site Number 840024
Fort Worth, Texas 76104

Investigational Site Number 840078
Charlottesville, Virginia 22908

Investigational Site Number 840025
Fairfax, Virginia 22030

Investigational Site Number 840072
Norfolk, Virginia 23507

Investigational Site Number 840054
Milwaukee, Wisconsin 53226

More Details

NCT ID
NCT00196742
Status
Recruiting
Sponsor
Genzyme, a Sanofi Company

Study Contact

Trial Transparency email recommended (Toll free number for US & Canada)
800-633-1610
Contact-Us@sanofi.com

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 - Vivian Liu, +65-6431-2548, Vivian.liu@genzyme.com

- 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.