Status:
COMPLETED
Replagal Enzyme Replacement Therapy for Adults With Fabry Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Fabry Disease
Eligibility:
MALE
Phase:
PHASE4
Brief Summary
This study will determine the safety and effectiveness of the drug Replagal for treating people with Fabry disease, an inherited metabolic disorder. In this disease, an enzyme called alpha-galactosida...
Detailed Description
Objectives: To evaluate the safety of the current standard Replagal treatment regimen of 0.2 mg/kg given intravenously every two weeks over an additional 6 months in patients who have completed 10 wee...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subject must have completed 10 weeks of infusions in Study TKT027 with intent to complete participation in the study.
- Subject must have adequate general health (as determined by the investigators) to undergo the specified phlebotomy regimen and protocol related procedures.
- Subject must consent to participate in the protocol and must have voluntarily signed an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient.
- EXCLUSION CRITERIA:
- Subject is unable to understand the nature, scope, and possible consequences of the study.
- Subject is unable to comply with the protocol, e.g., uncooperative with protocol schedule, refusal to agree to all of the study procedures, inability to return for safety evaluations, or is otherwise unlikely to complete the study, as determined by the investigator or the medical monitor.
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00097890
Start Date
November 1 2004
End Date
December 1 2005
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892