Status:
COMPLETED
An Open-Label Maintenance Study of the Enzyme Replacement Therapy Replagal in Patients With Fabry Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Fabry Disease
Eligibility:
MALE
39-45 years
Phase:
PHASE1
Brief Summary
This study will continue to evaluate the safety of using intravenous doses of Replagal for two patients with Fabry disease. Fabry disease is a genetic disorder inherited as an X-linked recessive trait...
Detailed Description
Objectives: This goal of this study is to continue treating two patients with Fabry disease using enzyme replacement therapy (ERT) using Replagal (agalsidase alfa) at a dose of 0.2 mg/kg of body weigh...
Eligibility Criteria
Inclusion
- Patients are under direct care of PI and have previously been treated with Replagal under TKT, Inc. sponsored study numbers 02-N-0220/TKT/010/015.
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00357786
Start Date
October 1 2003
Last Update
August 17 2011
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892