Status:
COMPLETED
A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Fabry Disease
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
People with Fabry Disease have an alteration in their genetic material (DNA) which causes a deficiency of the alpha-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that helps to break do...
Eligibility Criteria
Inclusion
- Patients must have successfully completed the previous double-blind study AGAL-008-00 (NCT00074984)
- 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
- The patient was unable to complete AGAL-008-00 (NCT00074984)
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00081497
Start Date
January 1 2004
End Date
September 1 2005
Last Update
April 2 2015
Active Locations (25)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0006
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
University of San Francisco
San Francisco, California, United States, 94143
4
University of Connecticut Health Partners
West Hartford, Connecticut, United States, 06119