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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: |
NCT00357786 |
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Date of registration:
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26/07/2006 |
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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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An Open-Label Maintenance Study of the Enzyme Replacement Therapy Replagal in Patients With Fabry Disease
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Scientific title:
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An Open-Label Maintenance Study of the Enzyme Replacement Therapy Replagal® (Registered Trademark) in Patients With Fabry Disease |
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Date of first enrolment:
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October 2003 |
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Target sample size:
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3 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00357786 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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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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- 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.
Age minimum:
39 Years
Age maximum:
45 Years
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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Primary Outcome(s)
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Kidney function
[Time Frame: 3 years]
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Secondary ID(s)
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040027
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04-N-0027
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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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