Fabry Disease Registry & Pregnancy Sub-registry

Recruiting

• Conditions: Fabry Disease

• Registration Number: NCT00196742
• Lead Sponsor: Genzyme, a Sanofi Company

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 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

Not available

Study Timeline

• Study Start: 2001-07-31
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Primary Completion: 2034-01-31
• Study Completion: 2034-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fabry Registry: To evaluate the long-term safety and effectiveness of Fabrazyme®	33 years	The primary purpose of this Registry is to describe the development and progression of Fabry disease in a representative global population. As Fabry is not a well-described disease this longitudinal program has a wide variety of "primary" outcomes including antibody testing as well as complication outcomes (eg, QoL, cognitive testing) which are measured over time. Additionally, as it is subject to what is collected by clinical sites at the time of visit it is unknown the amount of data that will be available for analyses.
Fabry Pregnancy Sub-registry: pregnancy outcomes, including complications and infant growth	33 years	The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Fabry disease during pregnancy, regardless of whether they receive disease-specific therapy, such as ERT with agalsidase beta.; This Sub-registry augments the routine monitoring and data collection recommended by the Fabry Registry. The Sub-registry aims to collect patient assessments from the ante- and perinatal periods and postpartum follow-up. Neonatal assessments and periodic pediatric assessments will also be collected.

Secondary Outcome Measures

Name	Time	Method
Fabry Register: Monitor factors associated with the efficacy of Fabry disease treatments	33 years	A secondary endpoint is to monitor those factors associated with the efficacy of Fabry disease treatments.

Trial Locations

Locations (282)

University of Alabama Birmingham- Nephrology- Site Number : 840018; 🇺🇸 Birmingham, Alabama, United States

University of Alabama Birmingham- Nephrology- Site Number : 840073; 🇺🇸 Birmingham, Alabama, United States

Phoenix Children's Hospital- Site Number : 840003; 🇺🇸 Phoenix, Arizona, United States

University of Arizona- Site Number : 840015; 🇺🇸 Tucson, Arizona, United States

Arkansas Childrens Hospital- Site Number : 840109; 🇺🇸 Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences- Site Number : 840113; 🇺🇸 Little Rock, Arkansas, United States

University of California at Irvine- Site Number : 840036; 🇺🇸 Irvine, California, United States

Southern California Permanente Medical Group- Site Number : 840108; 🇺🇸 Los Angeles, California, United States

USC Health Sciences Center Dept of Genetics- Site Number : 840082; 🇺🇸 Los Angeles, California, United States

UCLA School Of Medicine- Site Number : 840088; 🇺🇸 Los Angeles, California, United States

Children's Hospital Oakland- Site Number : 840029; 🇺🇸 Oakland, California, United States

Children's Hospital of Orange County- Site Number : 840074; 🇺🇸 Orange, California, United States

Stanford Unviersity MC Dept of Genetics- Site Number : 840022; 🇺🇸 Palo Alto, California, United States

UC Davis MIND Institute- Site Number : 840010; 🇺🇸 Sacramento, California, United States

Kaiser Permanente Hospital- Site Number : 840042; 🇺🇸 Sacramento, California, United States

Loma Linda University Children's Hospital- Site Number : 840117; 🇺🇸 San Bernardino, California, United States

University of California at San Diego- Site Number : 840007; 🇺🇸 San Diego, California, United States

University of California at San Francisco- Site Number : 840051; 🇺🇸 San Francisco, California, United States

Yale - Site Number : 840047; 🇺🇸 New Haven, Connecticut, United States

Children's National Medical Center- Site Number : 840067; 🇺🇸 Washington, District of Columbia, United States

University Hematology Oncology- Site Number : 840075; 🇺🇸 Coral Springs, Florida, United States

University of Florida Dept of Genetics- Site Number : 840083; 🇺🇸 Gainesville, Florida, United States

University of Florida Pediatrics Genetics- Site Number : 840121; 🇺🇸 Jacksonville, Florida, United States

The Atwal Clinic- Site Number : 840112; 🇺🇸 Jacksonville, Florida, United States

University Of Miami SOM- Site Number : 840006; 🇺🇸 Miami, Florida, United States

University of Florida-Genetics- Site Number : 840096; 🇺🇸 Tampa, Florida, United States

Emory University School of Medicine- Human Genetics- Site Number : 840060; 🇺🇸 Decatur, Georgia, United States

University of Colorado at Denver Genetics- Site Number : 840068; 🇺🇸 Aurora, Illinois, United States

Ann and Robert Lurie Children's Hospital- Site Number : 840013; 🇺🇸 Chicago, Illinois, United States

Rush University Medical Center Genetics- Site Number : 840079; 🇺🇸 Chicago, Illinois, United States

Indianapolis University School of Medicine- Site Number : 840027; 🇺🇸 Indianapolis, Indiana, United States

University of Iowa- Site Number : 840032; 🇺🇸 Iowa City, Iowa, United States

University of Kansas Medical Center- Site Number : 840071; 🇺🇸 Kansas City, Kansas, United States

University of Louisville- Genetics- Site Number : 840030; 🇺🇸 Louisville, Kentucky, United States

Ochsner Medical Center- Site Number : 840120; 🇺🇸 Baton Rouge, Louisiana, United States

Tulane University Medical Center- Site Number : 840001; 🇺🇸 New Orleans, Louisiana, United States

Maine Medical Center Pediatrics- Site Number : 840064; 🇺🇸 Portland, Maine, United States

John Hopkins- Site Number : 840044; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital-Genetics- Site Number : 840062; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital-Neurology- Site Number : 840103; 🇺🇸 Boston, Massachusetts, United States

Boston Children's Hospital- Site Number : 840092; 🇺🇸 Boston, Massachusetts, United States

Baystate Health- Site Number : 840002; 🇺🇸 Springfield, Massachusetts, United States

University of Michigan Pediatrics- Site Number : 840107; 🇺🇸 Ann Arbor, Michigan, United States

Children's Hospital of Michigan- Site Number : 840066; 🇺🇸 Detroit, Michigan, United States

Spectrum for Health- Site Number : 840019; 🇺🇸 Grand Rapids, Michigan, United States

Infusion Associates- Site Number : 840050; 🇺🇸 Grand Rapids, Michigan, United States

Children's Health Care- Site Number : 840114; 🇺🇸 Minneapolis, Minnesota, United States

Children's Hospital and Clinics of Minnesota- Site Number : 840046; 🇺🇸 Minneapolis, Minnesota, United States

University of Minnesota Medical Center Pediatrics- Site Number : 840076; 🇺🇸 Minneapolis, Minnesota, United States

University of Missouri Health System Department of Genetics- Site Number : 840031; 🇺🇸 Columibia, Missouri, United States

Washington University of St. Louis- Site Number : 840100; 🇺🇸 Saint Louis, Missouri, United States

Billings Clinic - Billings- Site Number : 840118; 🇺🇸 Billings, Montana, United States

Shodair Children's Hospital- Site Number : 840090; 🇺🇸 Helena, Montana, United States

University of Nebraska Medical Center- Pediatrics- Site Number : 840084; 🇺🇸 Omaha, Nebraska, United States

Children's Specialty Center of Nevada- Site Number : 840008; 🇺🇸 Las Vegas, Nevada, United States

Cooper Health Center- Site Number : 840098; 🇺🇸 Camden, New Jersey, United States

Joseph M. Sanzari Children's Hospital- Site Number : 840101; 🇺🇸 Hackensack, New Jersey, United States

Atlantic Health System- Site Number : 840099; 🇺🇸 Morristown, New Jersey, United States

St. Peter's University Hospital- Site Number : 840016; 🇺🇸 New Brunswick, New Jersey, United States

St. Joseph's Children's Hospital- Site Number : 840057; 🇺🇸 Paterson, New Jersey, United States

Northwell Health- Site Number : 840102; 🇺🇸 Manhasset, New York, United States

New York University School Of Medicine- Site Number : 840040; 🇺🇸 New York, New York, United States

Metropolitan Hospital Center- Site Number : 840110; 🇺🇸 New York, New York, United States

Icahn School of Medicine at Mount Sinai- Site Number : 840080; 🇺🇸 New York, New York, United States

University of Rochester Medical Center SOM- Site Number : 840105; 🇺🇸 Rochester, New York, United States

State University of New York- Site Number : 840052; 🇺🇸 Syracuse, New York, United States

New York Medical College- Site Number : 840039; 🇺🇸 Valhalla, New York, United States

Carolinas Medical Center- Site Number : 840065; 🇺🇸 Charlotte, North Carolina, United States

Duke University Medical Center Genetics Dept- Site Number : 840045; 🇺🇸 Durham, North Carolina, United States

Cincinnati Children's Hospital-Genetics- Site Number : 840033; 🇺🇸 Cincinnati, Ohio, United States

UHCMC- Site Number : 840119; 🇺🇸 Cleveland, Ohio, United States

Cleveland Clinic Foundation Pediatrics- Site Number : 840048; 🇺🇸 Cleveland, Ohio, United States

Nationwide Children's Hospital- Site Number : 840091; 🇺🇸 Columbus, Ohio, United States

Ohio State University Department of Genetics- Site Number : 840097; 🇺🇸 Columbus, Ohio, United States

LSD Data Registry Site LLC- Site Number : 840094; 🇺🇸 Dublin, Ohio, United States

Oregon Health and Science University- Site Number : 840116; 🇺🇸 Portland, Oregon, United States

Oregon Health and Scinece University- Site Number : 840038; 🇺🇸 Portland, Oregon, United States

Geisinger- Site Number : 840111; 🇺🇸 Danville, Pennsylvania, United States

Penn State University Medical Center-Neurology- Site Number : 840104; 🇺🇸 Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia HUP Medical Genetics- Site Number : 840089; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hospital of Philadelphia- Site Number : 840034; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh- Site Number : 840023; 🇺🇸 Pittsburgh, Pennsylvania, United States

Rhode Island Hospital Genetics- Site Number : 840053; 🇺🇸 Providence, Rhode Island, United States

Greenwood Genetcs- Site Number : 840055; 🇺🇸 Greenville, South Carolina, United States

Vanderbilt University Hospital-Pediatrics- Site Number : 840049; 🇺🇸 Nashville, Tennessee, United States

Baylor Research Center- Site Number : 840058; 🇺🇸 Dallas, Texas, United States

Cook Children's Health Care System- Site Number : 840024; 🇺🇸 Fort Worth, Texas, United States

University of Utah Department of Medical Genetics- Site Number : 840043; 🇺🇸 Salt Lake City, Utah, United States

University of Virginia School of Medicine-Pediatrics- Site Number : 840078; 🇺🇸 Charlottesville, Virginia, United States

O&O Alpan, LLC- Site Number : 840025; 🇺🇸 Fairfax, Virginia, United States

Children's Hospital of the Kings Daughters- Site Number : 840072; 🇺🇸 Norfolk, Virginia, United States

Seattle Children's Hospital- Site Number : 840028; 🇺🇸 Seattle, Washington, United States

University Of Washington Medical Center- Site Number : 840059; 🇺🇸 Seattle, Washington, United States

Multicare Health System ¿ Mary Bridge Childrens Hospital- Site Number : 840115; 🇺🇸 Tacoma, Washington, United States

Children's Hospital of Wisconsin-Pediatrics- Site Number : 840054; 🇺🇸 Milwaukee, Wisconsin, United States

Clínica Senhor do Bonfim LTDA- Site Number : 076008; 🇧🇷 Feira de Santana, Bahia, Brazil

Medicordis- Site Number : 076009; 🇧🇷 Brasília, Distrito Federal, Brazil

Hospital Geral e Maternidade de Cuiabá- Site Number : 076006; 🇧🇷 Cuiabá, Mato Grosso, Brazil

CTDR - Centro de Tratamento de Doenças Renais EIRELI- Site Number : 076007; 🇧🇷 Uberlândia, Minas Gerais, Brazil

Instituto do Rim do Paraná- Site Number : 076004; 🇧🇷 Curitiba, Paraná, Brazil

Instituto de Medicina Integral Professor Fernando Figueira - IMIP - Site Number : 076005; 🇧🇷 Recife, Pernambuco, Brazil

Saúde Center Clínica - Clínica Médica Nossa Senhora de Fátima - Site Number : 076002; 🇧🇷 Tapejara, Rio Grande Do Sul, Brazil

Hospital Universitário Professor Polydoro Ernani de São Thiago - UFSC- Site Number : 076012; 🇧🇷 Florianopolis, Santa Catarina, Brazil

Hospital e Maternidade Celso Pierro - PUC-Campinas- Site Number : 076013; 🇧🇷 Campinas, São Paulo, Brazil

Serviço de Terapia Renal de Ourinhos- Site Number : 076011; 🇧🇷 Ourinhos, São Paulo, Brazil

Instituto de Genética e Erros Inatos do Metabolismo - IGEIM- Site Number : 076001; 🇧🇷 São Paulo, Brazil

Investigational Site Number : 124005; 🇨🇦 Kingston, Ontario, Canada

Investigational Site Number : 152002; 🇨🇱 Santiago, Chile

Investigational Site Number : 153165; 🇨🇳 Beijing, China

Investigational Site Number : 153163; 🇨🇳 Shanghai, China

Investigational Site Number : 154208; 🇰🇷 Yangsan, Gyeongsangnam-do, Korea, Republic of

Investigational Site Number : 153228; 🇰🇷 Jeju-si, Korea, Republic of

Investigational Site Number : 151171; 🇳🇱 Amsterdam, Netherlands

Investigational Site Number : 153004; 🇳🇱 Amsterdam, Netherlands

Investigational Site Number : 153032; 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Investigational Site Number : 153172; 🇦🇷 Buenos Aires, Argentina

Investigational Site Number : 153130; 🇦🇷 Buenos Aires, Argentina

Investigational Site Number : 153194; 🇦🇷 Catamarca, Argentina

Investigational Site Number : 032005; 🇦🇷 La Rioja, Argentina

Investigational Site Number : 032004; 🇦🇷 Santa Fe, Argentina

Investigational Site Number : 036013; 🇦🇺 Westmead, New South Wales, Australia

Investigational Site Number : 151069; 🇦🇺 Westmead, New South Wales, Australia

Investigational Site Number : 153063; 🇦🇺 Brisbane, Queensland, Australia

Investigational Site Number : 151002; 🇦🇺 Adelaide, South Australia, Australia

Investigational Site Number : 153040; 🇦🇺 Parkville, Victoria, Australia

Investigational Site Number : 153090; 🇦🇺 Perth, Western Australia, Australia

Investigational Site Number : 150722; 🇧🇪 Antwerp, Belgium

Investigational Site Number : 153133; 🇧🇪 Antwerp, Belgium

Investigational Site Number : 153001; 🇧🇪 Brussels, Belgium

Investigational Site Number : 0560008; 🇧🇪 Brussels, Belgium

Investigational Site Number : 150517; 🇧🇪 Brussels, Belgium

Investigational Site Number : 151668; 🇧🇪 Leuven, Belgium

Investigational Site Number : 154275; 🇧🇪 Liège, Belgium

Investigational Site Number : 153100; 🇧🇪 Seraing, Belgium

Investigational Site Number : 153169; 🇧🇬 Sofia, Bulgaria

Investigational Site Number : 100001; 🇧🇬 Sofia, Bulgaria

Investigational Site Number : 124014; 🇨🇦 Calgary, Alberta, Canada

Investigational Site Number : 124002; 🇨🇦 Edmonton, Alberta, Canada

Investigational Site Number : 124010; 🇨🇦 Vancouver, British Columbia, Canada

Investigational Site Number : 124011; 🇨🇦 Vancouver, British Columbia, Canada

Investigational Site Number : 124019; 🇨🇦 Winnipeg, Manitoba, Canada

Investigational Site Number : 124022; 🇨🇦 Moncton, New Brunswick, Canada

Investigational Site Number : 124023; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

Investigational Site Number : 124008; 🇨🇦 Halifax, Nova Scotia, Canada

Investigational Site Number : 124021; 🇨🇦 London, Ontario, Canada

Investigational Site Number : 124006; 🇨🇦 Toronto, Ontario, Canada

Investigational Site Number : 124009; 🇨🇦 Toronto, Ontario, Canada

Investigational Site Number : 124013; 🇨🇦 Montreal, Quebec, Canada

Investigational Site Number : 124001; 🇨🇦 Sherbrooke, Quebec, Canada

Investigational Site Number : 152004; 🇨🇱 Antofagasta, Chile

Investigational Site Number : 152001; 🇨🇱 Coquimbo, Chile

Investigational Site Number : 152003; 🇨🇱 Iquique, Chile

Investigational Site Number : 152005; 🇨🇱 Vallenar, Chile

Investigational Site Number : 1560003; 🇨🇳 Hangzhou, China

Investigational Site Number : 1560002; 🇨🇳 Jinan, China

Investigational Site Number : 1560004; 🇨🇳 Nanjing, China

Investigational Site Number : 170001; 🇨🇴 Bogotá, Colombia

Investigational Site Number : 1910001; 🇭🇷 Rijena, Croatia

Investigational Site Number : 1910002; 🇭🇷 Zagreb, Croatia

Investigational Site Number : 153126; 🇨🇿 Praha 2, Czechia

Investigational Site Number : 153041; 🇩🇰 Copenhagen, Denmark

Investigational Site Number : 151229; 🇩🇰 København Ø, Denmark

Investigational Site Number : 153106; 🇪🇪 Tartu, Estonia

Investigational Site Number : 153024; 🇫🇮 Turku, Finland

Investigational Site Number : 250005; 🇫🇷 Bordeaux, France

Investigational Site Number : 250002; 🇫🇷 BRON Cedex, France

Investigational Site Number : 250001; 🇫🇷 Garches, France

Investigational Site Number : 250007; 🇫🇷 Lille, France

Investigational Site Number : 250003; 🇫🇷 Limoges, France

Investigational Site Number : 250006; 🇫🇷 Marseille, France

Investigational Site Number : 250004; 🇫🇷 St-priest-en-jarez, France

Investigational Site Number : 250009; 🇫🇷 Strasbourg, France

Investigational Site Number : 153013; 🇩🇪 Berlin, Germany

Investigational Site Number : 154150; 🇩🇪 Gießen, Germany

Investigational Site Number : 153147; 🇩🇪 Münster, Germany

Investigational Site Number : 153011; 🇩🇪 Würzburg, Germany

Investigational Site Number : 344001; 🇭🇰 Kowloon, Hong Kong

Investigational Site Number : 3480002; 🇭🇺 Budapest, Hungary

Investigational Site Number : 3480003; 🇭🇺 Létavértes, Hungary

Investigational Site Number : 3480005; 🇭🇺 Pécs, Hungary

Investigational Site Number : 3480004; 🇭🇺 Sopron, Hungary

Investigational Site Number : 356003; 🇮🇳 Ahmedabad, India

Investigational Site Number : 356001; 🇮🇳 Kolkata, India

Investigational Site Number : 3560004; 🇮🇳 Secunderabad, India

Investigational Site Number : 356002; 🇮🇳 Vellore, India

Investigational Site Number : 360001; 🇮🇩 Jakarta, Indonesia

Investigational Site Number : 380002; 🇮🇹 Bassano Del Grappa (VI), Italy

Investigational Site Number : 380004; 🇮🇹 Firenze, Italy

Investigational Site Number : 380013; 🇮🇹 Firenze, Italy

Investigational Site Number : 380005; 🇮🇹 Genova, Italy

Investigational Site Number : 380009; 🇮🇹 Milano, Italy

Investigational Site Number : 380006; 🇮🇹 Milano, Italy

Investigational Site Number : 380003; 🇮🇹 Modena, Italy

Investigational Site Number : 380010; 🇮🇹 Monza (MB), Italy

Investigational Site Number : 380008; 🇮🇹 Napoli, Italy

Investigational Site Number : 380007; 🇮🇹 Rimini, Italy

Investigational Site Number : 380012; 🇮🇹 Roma, Italy

Investigational Site Number : 380011; 🇮🇹 Torino, Italy

Investigational Site Number : 380001; 🇮🇹 Udine, Italy

Investigational Site Number : 380014; 🇮🇹 Vittoria (RG), Italy

Investigational Site Number : 153201; 🇯🇵 Nangoku-shi, Kochi, Japan

Investigational Site Number : 153205; 🇯🇵 Abeno-ku, Osaka, Japan

Investigational Site Number : 153217; 🇯🇵 Chiba, Japan

Investigational Site Number : 392007; 🇯🇵 Kobe, Japan

Investigational Site Number : 392006; 🇯🇵 Niigata, Japan

Investigational Site Number : 153204; 🇯🇵 Tokyo, Japan

Investigational Site Number : 151149; 🇰🇷 Seoul, Gyeonggi-do, Korea, Republic of

Investigational Site Number : 153178; 🇰🇷 Yangsan-si, Gyeongsangnam-do, Korea, Republic of

Investigational Site Number : 154148; 🇰🇷 Yangsan, Gyeongsangnam-do, Korea, Republic of

Investigational Site Number : 154246; 🇰🇷 Busan, Korea, Republic of

Investigational Site Number : 153191; 🇰🇷 Daejeon, Korea, Republic of

Investigational Site Number : 153225; 🇰🇷 Jeonnam, Korea, Republic of

Investigational Site Number : 153180; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number : 153196; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number : 153192; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number : 153188; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number : 153212; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number : 153222; 🇰🇷 Seoul, Korea, Republic of

Investigational Site Number : 154273; 🇰🇷 Suwon-si, Korea, Republic of

Investigational Site Number : 154225; 🇰🇼 Kuwait, Kuwait

Investigational Site Number : 154244; 🇱🇹 Vilnius, Lithuania

Investigational Site Number : 154652; 🇱🇹 Vilnius, Lithuania

Investigational Site Number : 458001; 🇲🇾 Jalan Pahang, Malaysia

Investigational Site Number : 458002; 🇲🇾 Kuala Lumpur, Malaysia

Investigational Site Number : 153141; 🇳🇴 Bergen, Norway

Investigational Site Number : 604002; 🇵🇪 Callao, Peru

Investigational Site Number : 608001; 🇵🇭 Manila, Philippines

Investigational Site Number : 150575; 🇵🇱 Warszawa, Poland

Investigational Site Number : 620005; 🇵🇹 Lisboa, Portugal

Investigational Site Number : 620001; 🇵🇹 Porto, Portugal

Investigational Site Number : 154099; 🇷🇴 Bucuresti, Romania

Investigational Site Number : 154164; 🇷🇴 Bucuresti, Romania

Investigational Site Number : 153081; 🇷🇴 Cluj-napoca, Romania

Investigational Site Number : 643001; 🇷🇺 Moscow, Russian Federation

Investigational Site Number : 643003; 🇷🇺 Nizhny Novgorod, Russian Federation

Investigational Site Number : 643002; 🇷🇺 Saint-Peterburg, Russian Federation

Investigational Site Number : 682002; 🇸🇦 Al Mubarraz, Saudi Arabia

Investigational Site Number : 6880001; 🇷🇸 Novi Sad, Serbia

Investigational Site Number : 702001; 🇸🇬 Singapore, Singapore

Investigational Site Number : 703001; 🇸🇰 Bratislava, Slovakia

Investigational Site Number : 705001; 🇸🇮 Slovenj Gradec, Slovenia

Investigational Site Number : 154146; 🇪🇸 A Coruña, Spain

Investigational Site Number : 154159; 🇪🇸 A Coruña, Spain

Investigational Site Number : 154135; 🇪🇸 Barakaldo, Spain

Investigational Site Number : 153067; 🇪🇸 Barcelona, Spain

Investigational Site Number : 153237; 🇪🇸 Barcelona, Spain

Investigational Site Number : 154147; 🇪🇸 Barcelona, Spain

Investigational Site Number : 154204; 🇪🇸 Barcelona, Spain

Investigational Site Number : 153077; 🇪🇸 Barcelona, Spain

Investigational Site Number : 154123; 🇪🇸 Barcelona, Spain

Investigational Site Number : 154136; 🇪🇸 Tarragona, Spain

Investigational Site Number : 153213; 🇪🇸 Vigo, Spain

Investigational Site Number : 153050; 🇸🇪 Göteborg, Sweden

Investigational Site Number : 151484; 🇸🇪 Stockholm, Sweden

Investigational Site Number : 153088; 🇨🇳 Kaohsiung City, Taiwan

Investigational Site Number : 154093; 🇨🇳 Chiayi, Taiwan

Investigational Site Number : 152152; 🇨🇳 Hualien, Taiwan

Investigational Site Number : 152246; 🇨🇳 Kaohsiung City, Taiwan

Investigational Site Number : 152244; 🇨🇳 Kaohsiung, Taiwan

Investigational Site Number : 151534; 🇨🇳 New Taipei City, Taiwan

Investigational Site Number : 151500; 🇨🇳 Putz City, Chia-yi, Taiwan

Investigational Site Number : 151179; 🇨🇳 Taichung, Taiwan

Investigational Site Number : 151181; 🇨🇳 Taichung, Taiwan

Investigational Site Number : 153248; 🇨🇳 Tainan City, Taiwan

Investigational Site Number : 764003; 🇹🇭 Bangkok, Thailand

Investigational Site Number : 152153; 🇨🇳 Tainan City, Taiwan

Investigational Site Number : 151182; 🇨🇳 Taipei City, Taiwan

Investigational Site Number : 152226; 🇨🇳 Taipei City, Taiwan

Investigational Site Number : 152321; 🇨🇳 Taipei, Taiwan

Investigational Site Number : 153158; 🇨🇳 Taoyuan City, Taiwan

Investigational Site Number : 764004; 🇹🇭 Bangkok, Thailand

Investigational Site Number : 764001; 🇹🇭 Bangkok, Thailand

Investigational Site Number : 764005; 🇹🇭 Khon Kaen, Thailand

Investigational Site Number : 151340; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom

Investigational Site Number : 154196; 🇬🇧 Belfast, United Kingdom

Investigational Site Number : 152287; 🇬🇧 Birmingham, United Kingdom

Investigational Site Number : 151646; 🇬🇧 London, United Kingdom

Investigational Site Number : 151123; 🇬🇧 London, United Kingdom

Investigational Site Number : 150303; 🇬🇧 London, United Kingdom

Investigational Site Number : 150455; 🇬🇧 Manchester, United Kingdom

Investigational Site Number : 152361; 🇬🇧 Salford, United Kingdom

Investigational Site Number : 154212; 🇻🇳 Hanoi, Vietnam