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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00097890 |
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Date of registration:
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30/11/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Replagal Enzyme Replacement Therapy for Adults With Fabry Disease
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Scientific title:
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An Open Label Six-Month Maintenance Clinical Trial of Replagal Enzyme Replacement Therapy in Patients With Fabry Disease Who Have Completed TKT027 |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00097890 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Fabry Disease
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Intervention(s)
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Drug: Replagal
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Drug: Replagal (Agalsidase Alfa)
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Secondary ID(s)
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05-N-0046
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050046
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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