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:
PHASE3
Brief Summary
People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. Fabrazyme is a drug that helps to breakdown and remove certain t...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients must have successfully completed the previous double-blind study (AGAL-1-002-98)
- 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 has undergone kidney transplant or is currently on dialysis
- 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
Exclusion
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00074971
Start Date
October 1 1999
End Date
December 1 2004
Last Update
December 4 2013
Active Locations (20)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of California San Fransisco
San Francisco, California, United States, 94143
3
Northwest Oncology & Hematology Associates
Coral Springs, Florida, United States, 33065
4
Children's Memorial Hospital
Chicago, Illinois, United States, 60614