A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease
NCT ID: NCT00074971
Last Updated: 2013-12-04
Study Results
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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COMPLETED
PHASE3
58 participants
INTERVENTIONAL
1999-10-31
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Fabrazyme (agalsidase beta)
Eligibility Criteria
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Inclusion Criteria
* Patients must provide written informed consent prior to study participation
* Female patients must have a negative pregnancy test prior to each dosing and use a medically accepted method of contraception throughout the study
Exclusion Criteria
* Patient is pregnant or lactating
* Patient is unwilling to comply with the requirements of the protocol
* Patient has a clinically significant organic disease (with the exception of symptoms related to Fabry disease), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would preclude participation in the study
16 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Genzyme Coporation
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme Coorporation
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California San Fransisco
San Francisco, California, United States
Northwest Oncology & Hematology Associates
Coral Springs, Florida, United States
Children's Memorial Hospital
Chicago, Illinois, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Fetal Diagnostic and Imaging Center
Billings, Montana, United States
University of New Mexico
Albuquerque, New Mexico, United States
Mount Sinai School of Medicine
New York, New York, United States
University of Rochester School of Medicine
Rochester, New York, United States
Hart Family Practice
Hickory, North Carolina, United States
Hematology/Oncology Associates of South Texas
San Antonio, Texas, United States
University of Washington School of Medicine
Seattle, Washington, United States
Hospital Edouard Herriot
Lyon, , France
Hospital Europeen Georges Pompidou
Paris, , France
Academisch Medisch Centrum
Amsterdam, , Netherlands
University of Puerto Rico
San Juan, , Puerto Rico
National Hospital for Neurology and Neurosurgery
London, , United Kingdom
Hope Hospital
Manchester, , United Kingdom
Countries
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References
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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.
Other Identifiers
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AGAL-005-99
Identifier Type: -
Identifier Source: org_study_id