Fabry Disease Registry & Pregnancy Sub-registry

NCT ID: NCT00196742

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

9000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-07-31

Study Completion Date

2034-01-31

Brief Summary

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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 primary 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;
* To evaluate the long-term safety and effectiveness of Fabrazyme®

Fabry Pregnancy Sub-registry: This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Fabry Registry, regardless of whether she is receiving disease-specific therapy (such as enzyme replacement therapy with agalsidase beta) and irrespective of the commercial product with which she may be treated. Data from the Sub-registry are also used to fulfill various global regulatory requirements, to support product development/reimbursement, and for other research and non-research-related purposes. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.

Detailed Description

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Conditions

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Fabry Disease

Keywords

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alpha Galactosidase A aGAL (alpha-galactosidase) Fabry GL3 (globotriaosylceramide) Anderson-Fabry Disease angiokeratomas GLA deficiency (gene deficiency) errors in metabolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients with Fabry disease

No experimental intervention is given. A patient with Fabry Disease will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.

No interventions assigned to this group

Pregnant women with confirmed diagnosis of Fabry

No experimental intervention is given. Pregnant women with confirmed diagnosis of Fabry that are participating in the Fabry Registry and consented to participate in the Fabry Sub-registry, regardless of whether she is receiving disease-specific therapy (such as ERT with agalsidase beta) and irrespective of the commercial product with which she may be treated.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

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University of Alabama Birmingham- Nephrology- Site Number : 840018

Birmingham, Alabama, United States

Site Status COMPLETED

University of Alabama Birmingham- Nephrology- Site Number : 840073

Birmingham, Alabama, United States

Site Status RECRUITING

Phoenix Children's Hospital- Site Number : 840003

Phoenix, Arizona, United States

Site Status RECRUITING

University of Arizona- Site Number : 840015

Tucson, Arizona, United States

Site Status RECRUITING

Arkansas Childrens Hospital- Site Number : 840109

Little Rock, Arkansas, United States

Site Status RECRUITING

University of Arkansas for Medical Sciences- Site Number : 840113

Little Rock, Arkansas, United States

Site Status RECRUITING

University of California at Irvine- Site Number : 840036

Irvine, California, United States

Site Status RECRUITING

Southern California Permanente Medical Group- Site Number : 840108

Los Angeles, California, United States

Site Status RECRUITING

USC Health Sciences Center Dept of Genetics- Site Number : 840082

Los Angeles, California, United States

Site Status COMPLETED

UCLA School Of Medicine- Site Number : 840088

Los Angeles, California, United States

Site Status RECRUITING

Children's Hospital Oakland- Site Number : 840029

Oakland, California, United States

Site Status COMPLETED

Children's Hospital of Orange County- Site Number : 840074

Orange, California, United States

Site Status RECRUITING

Stanford Unviersity MC Dept of Genetics- Site Number : 840022

Palo Alto, California, United States

Site Status RECRUITING

UC Davis MIND Institute- Site Number : 840010

Sacramento, California, United States

Site Status RECRUITING

Kaiser Permanente Hospital- Site Number : 840042

Sacramento, California, United States

Site Status COMPLETED

University of California at San Diego- Site Number : 840007

San Diego, California, United States

Site Status COMPLETED

University of California at San Francisco- Site Number : 840051

San Francisco, California, United States

Site Status RECRUITING

Yale - Site Number : 840047

New Haven, Connecticut, United States

Site Status RECRUITING

Children's National Medical Center- Site Number : 840067

Washington D.C., District of Columbia, United States

Site Status RECRUITING

University Hematology Oncology- Site Number : 840075

Coral Springs, Florida, United States

Site Status RECRUITING

University of Florida Dept of Genetics- Site Number : 840083

Gainesville, Florida, United States

Site Status RECRUITING

University of Florida Pediatrics Genetics- Site Number : 840121

Jacksonville, Florida, United States

Site Status RECRUITING

University Of Miami SOM- Site Number : 840006

Miami, Florida, United States

Site Status RECRUITING

University of Florida-Genetics- Site Number : 840096

Tampa, Florida, United States

Site Status RECRUITING

Emory University School of Medicine- Human Genetics- Site Number : 840060

Decatur, Georgia, United States

Site Status RECRUITING

University of Colorado at Denver Genetics- Site Number : 840068

Aurora, Illinois, United States

Site Status RECRUITING

Ann and Robert Lurie Children's Hospital- Site Number : 840013

Chicago, Illinois, United States

Site Status RECRUITING

Rush University Medical Center Genetics- Site Number : 840079

Chicago, Illinois, United States

Site Status RECRUITING

Indianapolis University School of Medicine- Site Number : 840027

Indianapolis, Indiana, United States

Site Status RECRUITING

University of Iowa- Site Number : 840032

Iowa City, Iowa, United States

Site Status RECRUITING

University of Kansas Medical Center- Site Number : 840071

Kansas City, Kansas, United States

Site Status RECRUITING

University of Louisville- Genetics- Site Number : 840030

Louisville, Kentucky, United States

Site Status COMPLETED

Ochsner Medical Center- Site Number : 840120

Baton Rouge, Louisiana, United States

Site Status RECRUITING

Tulane University Medical Center- Site Number : 840001

New Orleans, Louisiana, United States

Site Status COMPLETED

Maine Medical Center Pediatrics- Site Number : 840064

Portland, Maine, United States

Site Status RECRUITING

John Hopkins- Site Number : 840044

Baltimore, Maryland, United States

Site Status COMPLETED

Massachusetts General Hospital-Genetics- Site Number : 840062

Boston, Massachusetts, United States

Site Status RECRUITING

Boston Children's Hospital - PIN- Site Number : 840092

Boston, Massachusetts, United States

Site Status RECRUITING

Brigham and Women's Hospital-Neurology- Site Number : 840103

Boston, Massachusetts, United States

Site Status RECRUITING

Baystate Health- Site Number : 840002

Springfield, Massachusetts, United States

Site Status RECRUITING

University of Michigan Pediatrics- Site Number : 840107

Ann Arbor, Michigan, United States

Site Status RECRUITING

Children's Hospital of Michigan- Site Number : 840066

Detroit, Michigan, United States

Site Status RECRUITING

Spectrum for Health- Site Number : 840019

Grand Rapids, Michigan, United States

Site Status COMPLETED

Infusion Associates- Site Number : 840050

Grand Rapids, Michigan, United States

Site Status RECRUITING

Children's Hospital and Clinics of Minnesota- Site Number : 840046

Minneapolis, Minnesota, United States

Site Status COMPLETED

Children's Hospitals and Clinics of Minnesota- Site Number : 840114

Minneapolis, Minnesota, United States

Site Status RECRUITING

University of Minnesota Medical Center Pediatrics- Site Number : 840076

Minneapolis, Minnesota, United States

Site Status RECRUITING

University of Missouri Health System Department of Genetics- Site Number : 840031

Columbia, Missouri, United States

Site Status RECRUITING

Washington University of St. Louis- Site Number : 840100

St Louis, Missouri, United States

Site Status RECRUITING

Shodair Children's Hospital- Site Number : 840090

Helena, Montana, United States

Site Status COMPLETED

University of Nebraska Medical Center- Pediatrics- Site Number : 840084

Omaha, Nebraska, United States

Site Status RECRUITING

Children's Specialty Center of Nevada- Site Number : 840008

Las Vegas, Nevada, United States

Site Status RECRUITING

Cooper Health Center- Site Number : 840098

Camden, New Jersey, United States

Site Status TERMINATED

Joseph M. Sanzari Children's Hospital- Site Number : 840101

Hackensack, New Jersey, United States

Site Status RECRUITING

Atlantic Health System- Site Number : 840099

Morristown, New Jersey, United States

Site Status RECRUITING

St. Peter's University Hospital- Site Number : 840016

New Brunswick, New Jersey, United States

Site Status RECRUITING

St. Joseph's Children's Hospital- Site Number : 840057

Paterson, New Jersey, United States

Site Status RECRUITING

Northwell Health- Site Number : 840102

Manhasset, New York, United States

Site Status RECRUITING

New York University School Of Medicine- Site Number : 840040

New York, New York, United States

Site Status RECRUITING

Metropolitan Hospital Center- Site Number : 840110

New York, New York, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai- Site Number : 840080

New York, New York, United States

Site Status RECRUITING

University of Rochester Medical Center SOM- Site Number : 840105

Rochester, New York, United States

Site Status COMPLETED

State University of New York- Site Number : 840052

Syracuse, New York, United States

Site Status RECRUITING

New York Medical College- Site Number : 840039

Valhalla, New York, United States

Site Status RECRUITING

Carolinas Medical Center- Site Number : 840065

Charlotte, North Carolina, United States

Site Status RECRUITING

Duke University Medical Center Genetics Dept- Site Number : 840045

Durham, North Carolina, United States

Site Status RECRUITING

Cincinnati Children's Hospital-Genetics- Site Number : 840033

Cincinnati, Ohio, United States

Site Status RECRUITING

University Hospitals Cleveland Medical Center- Site Number : 840119

Cleveland, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Foundation Pediatrics- Site Number : 840048

Cleveland, Ohio, United States

Site Status RECRUITING

Nationwide Children's Hospital - PIN- Site Number : 840091

Columbus, Ohio, United States

Site Status RECRUITING

Ohio State University Department of Genetics- Site Number : 840097

Columbus, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

LSD Data Registry Site LLC- Site Number : 840094

Dublin, Ohio, United States

Site Status RECRUITING

Oregon Health & Science University (OHSU)- Site Number : 840116

Portland, Oregon, United States

Site Status RECRUITING

Oregon Health and Scinece University- Site Number : 840038

Portland, Oregon, United States

Site Status TERMINATED

Geisinger- Site Number : 840111

Danville, Pennsylvania, United States

Site Status RECRUITING

Penn State University Medical Center-Neurology- Site Number : 840104

Hershey, Pennsylvania, United States

Site Status RECRUITING

Children's Hospital of Philadelphia HUP Medical Genetics- Site Number : 840089

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Children's Hospital of Philadelphia- Site Number : 840034

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Pittsburgh- Site Number : 840023

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Rhode Island Hospital Genetics- Site Number : 840053

Providence, Rhode Island, United States

Site Status COMPLETED

Greenwood Genetcs- Site Number : 840055

Greenville, South Carolina, United States

Site Status RECRUITING

Vanderbilt University Hospital-Pediatrics- Site Number : 840049

Nashville, Tennessee, United States

Site Status RECRUITING

Baylor Research Center- Site Number : 840058

Dallas, Texas, United States

Site Status RECRUITING

Cook Children's Health Care System- Site Number : 840024

Fort Worth, Texas, United States

Site Status RECRUITING

University of Utah Department of Medical Genetics- Site Number : 840043

Salt Lake City, Utah, United States

Site Status RECRUITING

University of Virginia School of Medicine-Pediatrics- Site Number : 840078

Charlottesville, Virginia, United States

Site Status COMPLETED

O&O Alpan, LLC- Site Number : 840025

Fairfax, Virginia, United States

Site Status RECRUITING

Children's Hospital of the Kings Daughters- Site Number : 840072

Norfolk, Virginia, United States

Site Status COMPLETED

Seattle Children's Hospital- Site Number : 840028

Seattle, Washington, United States

Site Status RECRUITING

University Of Washington Medical Center- Site Number : 840059

Seattle, Washington, United States

Site Status RECRUITING

Mary Bridge Children's Outpatient Center- Site Number : 840115

Tacoma, Washington, United States

Site Status RECRUITING

Children's Hospital of Wisconsin-Pediatrics- Site Number : 840054

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Investigational Site Number : 153280

Berazategui, Buenos Aires, Argentina

Site Status RECRUITING

Investigational Site Number : 153260

Caba, Buenos Aires, Buenos Aires, Argentina

Site Status RECRUITING

Investigational Site Number : 153032

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status COMPLETED

Investigational Site Number : 153250

San Isidro, Buenos Aires, Buenos Aires, Argentina

Site Status RECRUITING

Investigational Site Number : 153194

Catamarca, Catamarca Province, Argentina

Site Status RECRUITING

Investigational Site Number : 153172

Buenos Aires, , Argentina

Site Status COMPLETED

Investigational Site Number : 153130

Buenos Aires, , Argentina

Site Status COMPLETED

Investigational Site Number : 032005

La Rioja, , Argentina

Site Status COMPLETED

Investigational Site Number : 153270

La Rioja Province, , Argentina

Site Status RECRUITING

Investigational Site Number : 032004

Santa Fe, , Argentina

Site Status RECRUITING

Investigational Site Number : 036013

Westmead, New South Wales, Australia

Site Status RECRUITING

Investigational Site Number : 151069

Westmead, New South Wales, Australia

Site Status RECRUITING

Investigational Site Number : 153063

Brisbane, Queensland, Australia

Site Status RECRUITING

Investigational Site Number : 151002

Adelaide, South Australia, Australia

Site Status RECRUITING

Investigational Site Number : 153040

Parkville, Victoria, Australia

Site Status RECRUITING

Investigational Site Number : 153090

Perth, Western Australia, Australia

Site Status RECRUITING

Investigational Site Number : 150722

Antwerp, , Belgium

Site Status RECRUITING

Investigational Site Number : 153133

Antwerp, , Belgium

Site Status RECRUITING

Investigational Site Number : 153001

Brussels, , Belgium

Site Status RECRUITING

Investigational Site Number : 0560008

Brussels, , Belgium

Site Status RECRUITING

Investigational Site Number : 150517

Brussels, , Belgium

Site Status RECRUITING

Investigational Site Number : 151668

Leuven, , Belgium

Site Status RECRUITING

Investigational Site Number : 154275

Liège, , Belgium

Site Status RECRUITING

Investigational Site Number : 153100

Seraing, , Belgium

Site Status RECRUITING

Clínica Senhor do Bonfim LTDA- Site Number : 076008

Feira de Santana, Estado de Bahia, Brazil

Site Status RECRUITING

Medicordis- Site Number : 076009

Brasília, Federal District, Brazil

Site Status RECRUITING

Hospital Geral e Maternidade de Cuiabá- Site Number : 076006

Cuiabá, Mato Grosso, Brazil

Site Status RECRUITING

CTDR - Centro de Tratamento de Doenças Renais EIRELI- Site Number : 076007

Uberlândia, Minas Gerais, Brazil

Site Status RECRUITING

Instituto do Rim do Paraná- Site Number : 076004

Curitiba, Paraná, Brazil

Site Status RECRUITING

Instituto de Medicina Integral Professor Fernando Figueira - IMIP - Site Number : 076005

Recife, Pernambuco, Brazil

Site Status RECRUITING

Saúde Center Clínica - Clínica Médica Nossa Senhora de Fátima - Site Number : 076002

Tapejara, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital Universitário Professor Polydoro Ernani de São Thiago - UFSC- Site Number : 076012

Florianópolis, Santa Catarina, Brazil

Site Status RECRUITING

Hospital e Maternidade Celso Pierro - PUC-Campinas- Site Number : 076013

Campinas, São Paulo, Brazil

Site Status RECRUITING

Serviço de Terapia Renal de Ourinhos- Site Number : 076011

Ourinhos, São Paulo, Brazil

Site Status RECRUITING

Instituto de Genética e Erros Inatos do Metabolismo- Site Number : 076001

São Paulo, , Brazil

Site Status RECRUITING

Investigational Site Number : 153169

Sofia, , Bulgaria

Site Status COMPLETED

Investigational Site Number : 100001

Sofia, , Bulgaria

Site Status RECRUITING

Investigational Site Number : 124014

Calgary, Alberta, Canada

Site Status RECRUITING

Investigational Site Number : 124002

Edmonton, Alberta, Canada

Site Status RECRUITING

Investigational Site Number : 124010

Vancouver, British Columbia, Canada

Site Status RECRUITING

Investigational Site Number : 124011

Vancouver, British Columbia, Canada

Site Status COMPLETED

Investigational Site Number : 124019

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Investigational Site Number : 124022

Moncton, New Brunswick, Canada

Site Status RECRUITING

Investigational Site Number : 124023

St. John's, Newfoundland and Labrador, Canada

Site Status RECRUITING

Investigational Site Number : 124008

Halifax, Nova Scotia, Canada

Site Status RECRUITING

Investigational Site Number : 124005

Kingston, Ontario, Canada

Site Status TERMINATED

Investigational Site Number : 124021

London, Ontario, Canada

Site Status RECRUITING

Investigational Site Number : 124006

Toronto, Ontario, Canada

Site Status RECRUITING

Investigational Site Number : 124009

Toronto, Ontario, Canada

Site Status RECRUITING

Investigational Site Number : 124013

Montreal, Quebec, Canada

Site Status RECRUITING

Investigational Site Number : 124001

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Investigational Site Number : 152004

Antofagasta, , Chile

Site Status RECRUITING

Investigational Site Number : 152001

Coquimbo, , Chile

Site Status RECRUITING

Investigational Site Number : 152003

Iquique, , Chile

Site Status COMPLETED

Investigational Site Number : 152002

Santiago, , Chile

Site Status TERMINATED

Investigational Site Number : 152005

Vallenar, , Chile

Site Status RECRUITING

Investigational Site Number : 153165

Beijing, , China

Site Status TERMINATED

Investigational Site Number : 1560003

Hangzhou, , China

Site Status RECRUITING

Investigational Site Number : 1560002

Jinan, , China

Site Status RECRUITING

Investigational Site Number : 1560004

Nanjing, , China

Site Status RECRUITING

Investigational Site Number : 1560001

Shanghai, , China

Site Status RECRUITING

Investigational Site Number : 153163

Shanghai, , China

Site Status TERMINATED

Investigational Site Number : 170001

Bogotá, , Colombia

Site Status RECRUITING

Investigational Site Number : 1910001

Rijeka, , Croatia

Site Status COMPLETED

Investigational Site Number : 1910002

Zagreb, , Croatia

Site Status RECRUITING

Investigational Site Number : 153126

Prague, , Czechia

Site Status RECRUITING

Investigational Site Number : 153041

Copenhagen, , Denmark

Site Status RECRUITING

Investigational Site Number : 151229

København Ø, , Denmark

Site Status COMPLETED

Investigational Site Number : 153106

Tartu, , Estonia

Site Status RECRUITING

Investigational Site Number : 153024

Turku, , Finland

Site Status RECRUITING

Investigational Site Number : 250005

Bordeaux, , France

Site Status RECRUITING

Investigational Site Number : 250002

Bron, , France

Site Status RECRUITING

Investigational Site Number : 250001

Garches, , France

Site Status RECRUITING

Investigational Site Number : 250007

Lille, , France

Site Status RECRUITING

Investigational Site Number : 250004

Saint-Priest-en-Jarez, , France

Site Status RECRUITING

Investigational Site Number : 250009

Strasbourg, , France

Site Status RECRUITING

Investigational Site Number : 153013

Berlin, , Germany

Site Status RECRUITING

Investigational Site Number : 154150

Giessen, , Germany

Site Status RECRUITING

Investigational Site Number : 153147

Münster, , Germany

Site Status RECRUITING

Investigational Site Number : 153011

Würzburg, , Germany

Site Status RECRUITING

Investigational Site Number : 344001

Kowloon, , Hong Kong

Site Status RECRUITING

Investigational Site Number : 3480002

Budapest, , Hungary

Site Status RECRUITING

Investigational Site Number : 3480003

Létavértes, , Hungary

Site Status RECRUITING

Investigational Site Number : 3480005

Pécs, , Hungary

Site Status RECRUITING

Investigational Site Number : 3480004

Sopron, , Hungary

Site Status RECRUITING

Investigational Site Number : 356003

Ahmedabad, , India

Site Status RECRUITING

Investigational Site Number : 356001

Kolkata, , India

Site Status RECRUITING

Investigational Site Number : 3560004

Secunderabad, , India

Site Status RECRUITING

Investigational Site Number : 356002

Vellore, , India

Site Status RECRUITING

Investigational Site Number : 360001

Jakarta, , Indonesia

Site Status RECRUITING

Investigational Site Number : 380002

Bassano del Grappa, , Italy

Site Status RECRUITING

Investigational Site Number : 380019

Bologna, , Italy

Site Status RECRUITING

Investigational Site Number : 380004

Florence, , Italy

Site Status RECRUITING

Investigational Site Number : 380013

Florence, , Italy

Site Status RECRUITING

Investigational Site Number : 380005

Genova, , Italy

Site Status RECRUITING

Investigational Site Number : 380009

Milan, , Italy

Site Status COMPLETED

Investigational Site Number : 380006

Milan, , Italy

Site Status COMPLETED

Investigational Site Number : 380003

Modena, , Italy

Site Status RECRUITING

Investigational Site Number : 380010

Monza, , Italy

Site Status RECRUITING

Investigational Site Number : 380008

Napoli, , Italy

Site Status RECRUITING

Investigational Site Number : 380007

Rimini, , Italy

Site Status COMPLETED

Investigational Site Number : 380012

Roma, , Italy

Site Status RECRUITING

Investigational Site Number : 380011

Torino, , Italy

Site Status RECRUITING

Investigational Site Number : 380001

Udine, , Italy

Site Status RECRUITING

Investigational Site Number : 380014

Vittoria, , Italy

Site Status RECRUITING

Investigational Site Number : 392007

Kobe, Hyōgo, Japan

Site Status ACTIVE_NOT_RECRUITING

Investigational Site Number : 153201

Nangoku-shi, Kochi, Japan

Site Status RECRUITING

Investigational Site Number : 153205

Abeno-ku, Osaka, Japan

Site Status COMPLETED

Investigational Site Number : 153217

Chiba, , Japan

Site Status RECRUITING

Investigational Site Number : 392006

Niigata, , Japan

Site Status RECRUITING

Investigational Site Number : 153204

Tokyo, , Japan

Site Status RECRUITING

Investigational Site Number : 154244

Vilnius, , Lithuania

Site Status RECRUITING

Investigational Site Number : 154652

Vilnius, , Lithuania

Site Status RECRUITING

Investigational Site Number : 458002

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Investigational Site Number : 458001

Kuala Pahang, , Malaysia

Site Status RECRUITING

Investigational Site Number : 151171

Amsterdam, , Netherlands

Site Status TERMINATED

Investigational Site Number : 153004

Amsterdam, , Netherlands

Site Status TERMINATED

Investigational Site Number : 153141

Bergen, , Norway

Site Status RECRUITING

Investigational Site Number : 604002

Callao, , Peru

Site Status RECRUITING

Investigational Site Number : 608001

Manila, , Philippines

Site Status RECRUITING

Investigational Site Number : 150575

Warsaw, , Poland

Site Status RECRUITING

Investigational Site Number : 620005

Lisbon, , Portugal

Site Status RECRUITING

Investigational Site Number : 620001

Porto, , Portugal

Site Status RECRUITING

Investigational Site Number : 154099

Bucharest, , Romania

Site Status RECRUITING

Investigational Site Number : 154164

Bucharest, , Romania

Site Status RECRUITING

Investigational Site Number : 153081

Cluj-Napoca, , Romania

Site Status COMPLETED

Investigational Site Number : 643001

Moscow, , Russia

Site Status RECRUITING

Investigational Site Number : 643003

Nizhny Novgorod, , Russia

Site Status RECRUITING

Investigational Site Number : 643002

Saint-Peterburg, , Russia

Site Status RECRUITING

Investigational Site Number : 682002

Al Mubarraz, , Saudi Arabia

Site Status RECRUITING

Investigational Site Number : 6880001

Novi Sad, , Serbia

Site Status RECRUITING

Investigational Site Number : 702001

Singapore, , Singapore

Site Status RECRUITING

Investigational Site Number : 703001

Bratislava, , Slovakia

Site Status COMPLETED

Investigational Site Number : 705001

Slovenj Gradec, , Slovenia

Site Status RECRUITING

Investigational Site Number : 153178

Yangsan, Gyeongsangnam-do, South Korea

Site Status COMPLETED

Investigational Site Number : 154208

Yangsan, Gyeongsangnam-do, South Korea

Site Status TERMINATED

Investigational Site Number : 157176

Yangsan, Gyeongsangnam-do, South Korea

Site Status RECRUITING

Investigational Site Number : 153180

Seoul, Seoul-teukbyeolsi, South Korea

Site Status RECRUITING

Investigational Site Number : 153196

Seoul, Seoul-teukbyeolsi, South Korea

Site Status RECRUITING

Investigational Site Number : 154246

Busan, , South Korea

Site Status RECRUITING

Investigational Site Number : 153191

Daejeon, , South Korea

Site Status RECRUITING

Investigational Site Number : 153228

Jeju City, , South Korea

Site Status TERMINATED

Investigational Site Number : 153192

Seoul, , South Korea

Site Status COMPLETED

Investigational Site Number : 151149

Seoul, , South Korea

Site Status RECRUITING

Investigational Site Number : 153188

Seoul, , South Korea

Site Status RECRUITING

Investigational Site Number : 153212

Seoul, , South Korea

Site Status RECRUITING

Investigational Site Number : 153222

Seoul, , South Korea

Site Status RECRUITING

Investigational Site Number : 154273

Suwon, , South Korea

Site Status RECRUITING

Investigational Site Number : 154146

A Coruña, A Coruña [La Coruña], Spain

Site Status COMPLETED

Investigational Site Number : 154159

A Coruña, A Coruña [La Coruña], Spain

Site Status COMPLETED

Investigational Site Number : 153237

Barcelona, Barcelona [Barcelona], Spain

Site Status RECRUITING

Investigational Site Number : 154147

Barcelona, Barcelona [Barcelona], Spain

Site Status RECRUITING

Investigational Site Number : 154135

Barakaldo, Basque Country, Spain

Site Status COMPLETED

Investigational Site Number : 154204

Barcelona, Catalunya [Cataluña], Spain

Site Status RECRUITING

Investigational Site Number : 153213

Vigo, Pontevedra [Pontevedra], Spain

Site Status RECRUITING

Investigational Site Number : 154136

Tarragona, Tarragona [Tarragona], Spain

Site Status RECRUITING

Investigational Site Number : 153067

Barcelona, , Spain

Site Status RECRUITING

Investigational Site Number : 153077

Barcelona, , Spain

Site Status RECRUITING

Investigational Site Number : 154123

Barcelona, , Spain

Site Status RECRUITING

Investigational Site Number : 153050

Gothenburg, , Sweden

Site Status RECRUITING

Investigational Site Number : 151484

Stockholm, , Sweden

Site Status RECRUITING

Investigational Site Number : 151500

Chiayi City, , Taiwan

Site Status RECRUITING

Investigational Site Number : 154093

Chiayi City, , Taiwan

Site Status RECRUITING

Investigational Site Number : 152152

Hualien City, , Taiwan

Site Status RECRUITING

Investigational Site Number : 152244

Kaohsiung City, , Taiwan

Site Status COMPLETED

Investigational Site Number : 153088

Kaohsiung City, , Taiwan

Site Status COMPLETED

Investigational Site Number : 152246

Kaohsiung City, , Taiwan

Site Status RECRUITING

Investigational Site Number : 151534

New Taipei City, , Taiwan

Site Status RECRUITING

Investigational Site Number : 151179

Taichung, , Taiwan

Site Status RECRUITING

Investigational Site Number : 151181

Taichung, , Taiwan

Site Status RECRUITING

Investigational Site Number : 153248

Tainan, , Taiwan

Site Status RECRUITING

Investigational Site Number : 152153

Tainan, , Taiwan

Site Status RECRUITING

Investigational Site Number : 151182

Taipei, , Taiwan

Site Status RECRUITING

Investigational Site Number : 152321

Taipei, , Taiwan

Site Status RECRUITING

Investigational Site Number : 152226

Taipei, , Taiwan

Site Status RECRUITING

Investigational Site Number : 153158

Tao Yuan County, , Taiwan

Site Status RECRUITING

Investigational Site Number : 764003

Bangkok, , Thailand

Site Status RECRUITING

Investigational Site Number : 764004

Bangkok, , Thailand

Site Status RECRUITING

Investigational Site Number : 764001

Bangkok, , Thailand

Site Status RECRUITING

Investigational Site Number : 764005

Khon Kaen, , Thailand

Site Status RECRUITING

Investigational Site Number : 151340

Cambridge, Cambridgeshire, United Kingdom

Site Status RECRUITING

Investigational Site Number : 150303

London, London, City of, United Kingdom

Site Status RECRUITING

Investigational Site Number : 152361

Salford, Manchester, United Kingdom

Site Status RECRUITING

Investigational Site Number : 150455

Manchester, Missouri, United Kingdom

Site Status RECRUITING

Investigational Site Number : 154196

Belfast, , United Kingdom

Site Status RECRUITING

Investigational Site Number : 152287

Birmingham, , United Kingdom

Site Status RECRUITING

Investigational Site Number : 151123

London, , United Kingdom

Site Status RECRUITING

Investigational Site Number : 151646

London, , United Kingdom

Site Status RECRUITING

Investigational Site Number : 154212

Hanoi, , Vietnam

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Kuwait Switzerland United Arab Emirates United States Argentina Australia Belgium Brazil Bulgaria Canada Chile China Colombia Croatia Czechia Denmark Estonia Finland France Germany Hong Kong Hungary India Indonesia Italy Japan Lithuania Malaysia Netherlands Norway Peru Philippines Poland Portugal Romania Russia Saudi Arabia Serbia Singapore Slovakia Slovenia South Korea Spain Sweden Taiwan Thailand United Kingdom Vietnam

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Trial Transparency

Role: CONTACT

Phone: 800-633-1610

Email: [email protected]

Fabry Registry HelpLine

Role: CONTACT

Phone: 617-591-5500

References

Explore related publications, articles, or registry entries linked to this study.

Germain DP, Brand E, Burlina A, Cecchi F, Garman SC, Kempf J, Laney DA, Linhart A, Marodi L, Nicholls K, Ortiz A, Pieruzzi F, Shankar SP, Waldek S, Wanner C, Jovanovic A. Phenotypic characteristics of the p.Asn215Ser (p.N215S) GLA mutation in male and female patients with Fabry disease: A multicenter Fabry Registry study. Mol Genet Genomic Med. 2018 Apr 12;6(4):492-503. doi: 10.1002/mgg3.389. Online ahead of print.

Reference Type BACKGROUND
PMID: 29649853 (View on PubMed)

Wilcox WR, Feldt-Rasmussen U, Martins AM, Ortiz A, Lemay RM, Jovanovic A, Germain DP, Varas C, Nicholls K, Weidemann F, Hopkin RJ. Improvement of Fabry Disease-Related Gastrointestinal Symptoms in a Significant Proportion of Female Patients Treated with Agalsidase Beta: Data from the Fabry Registry. JIMD Rep. 2018;38:45-51. doi: 10.1007/8904_2017_28. Epub 2017 May 17.

Reference Type BACKGROUND
PMID: 28510034 (View on PubMed)

Hopkin RJ, Cabrera G, Charrow J, Lemay R, Martins AM, Mauer M, Ortiz A, Patel MR, Sims K, Waldek S, Warnock DG, Wilcox WR. Risk factors for severe clinical events in male and female patients with Fabry disease treated with agalsidase beta enzyme replacement therapy: Data from the Fabry Registry. Mol Genet Metab. 2016 Sep;119(1-2):151-9. doi: 10.1016/j.ymgme.2016.06.007. Epub 2016 Jun 13.

Reference Type BACKGROUND
PMID: 27510433 (View on PubMed)

Hopkin RJ, Cabrera GH, Jefferies JL, Yang M, Ponce E, Brand E, Feldt-Rasmussen U, Germain DP, Guffon N, Jovanovic A, Kantola I, Karaa A, Martins AM, Tondel C, Wilcox WR, Yoo HW, Burlina AP, Mauer M. Clinical outcomes among young patients with Fabry disease who initiated agalsidase beta treatment before 30 years of age: An analysis from the Fabry Registry. Mol Genet Metab. 2023 Feb;138(2):106967. doi: 10.1016/j.ymgme.2022.106967. Epub 2022 Nov 30.

Reference Type DERIVED
PMID: 36709533 (View on PubMed)

Wanner C, Feldt-Rasmussen U, Ortiz A. Plain language summary of a study looking at heart muscle thickness and kidney function in women with Fabry disease who received agalsidase beta treatment. Future Cardiol. 2022 Sep;18(10):755-763. doi: 10.2217/fca-2022-0047. Epub 2022 Sep 8.

Reference Type DERIVED
PMID: 36073247 (View on PubMed)

Ortiz A, Abiose A, Bichet DG, Cabrera G, Charrow J, Germain DP, Hopkin RJ, Jovanovic A, Linhart A, Maruti SS, Mauer M, Oliveira JP, Patel MR, Politei J, Waldek S, Wanner C, Yoo HW, Warnock DG. Time to treatment benefit for adult patients with Fabry disease receiving agalsidase beta: data from the Fabry Registry. J Med Genet. 2016 Jul;53(7):495-502. doi: 10.1136/jmedgenet-2015-103486. Epub 2016 Mar 18.

Reference Type DERIVED
PMID: 26993266 (View on PubMed)

Germain DP, Charrow J, Desnick RJ, Guffon N, Kempf J, Lachmann RH, Lemay R, Linthorst GE, Packman S, Scott CR, Waldek S, Warnock DG, Weinreb NJ, Wilcox WR. Ten-year outcome of enzyme replacement therapy with agalsidase beta in patients with Fabry disease. J Med Genet. 2015 May;52(5):353-8. doi: 10.1136/jmedgenet-2014-102797. Epub 2015 Mar 20.

Reference Type DERIVED
PMID: 25795794 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AGAL19211

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1294-8298

Identifier Type: REGISTRY

Identifier Source: secondary_id

DIREGC07006

Identifier Type: -

Identifier Source: org_study_id