A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease
NCT ID: NCT00081497
Last Updated: 2015-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
67 participants
INTERVENTIONAL
2004-01-31
2005-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fabrazyme 1.0 mg/kg every 2 weeks
This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
agalsidase beta
1.0 mg/kg every 2 weeks
Interventions
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agalsidase beta
1.0 mg/kg every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must provide written informed consent prior to study participation
* Female patients of childbearing potential must have a negative pregnancy test prior to each dosing and all female patients must use a medically accepted form of contraception throughout the study
Exclusion Criteria
* The patient has undergone kidney transplantation or is currently on dialysis
* The patient has diabetes mellitus or presence of confounding renal disease
* The patient has a clinically significant organic disease or an unstable condition that precludes participation
* The patient is unwilling to comply with the protocol requirements
16 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Genzyme Corporation
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of San Francisco
San Francisco, California, United States
University of Connecticut Health Partners
West Hartford, Connecticut, United States
Oncology Hematology Association
Coral Springs, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Children's Memorial Hospital
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Gene Therapy Center - Department of Pediatrics and Institute of Human Genetics
Minneapolis, Minnesota, United States
Children's Hospital
Buffalo, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
University of Rochester School of Medicine
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
University of Washington School of Medicine
Seattle, Washington, United States
Queen Elizabeth II Health Center
Halifax, Nova Scotia, Canada
North York General Hospital
Toronto, Ontario, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
University Hospital
Prague, , Czechia
Sopron Megyei Jogu Varos Erzsebet Korhaz
Sopron, , Hungary
Klinika Chorob Metabolicznych Instytut
Warsaw, , Poland
Hope Hospital
Manchester, , United Kingdom
Countries
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Other Identifiers
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AGAL02503
Identifier Type: -
Identifier Source: org_study_id
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