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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: |
NCT01997489 |
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Date of registration:
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18/11/2013 |
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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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Ophthalmic Findings During 10-year Enzyme Substitution of Danish Fabry Patients.
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Scientific title:
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Ophthalmic Findings During 10-year Enzyme Substitution of Danish Fabry Patients |
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Date of first enrolment:
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September 2001 |
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Target sample size:
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39 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01997489 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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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Denmark
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Contacts
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Name:
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Ulla Feldt-Rasmussen, MD, DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All Danish patients with Fabry disease before starting therapy
Exclusion Criteria:
- Missing values for eye examination at baseline or follow-up
Age minimum:
15 Years
Age maximum:
N/A
Gender:
Both
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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: Enzyme replacement
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Primary Outcome(s)
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cornea vercillitata
[Time Frame: change from baseline to 10 years]
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Secondary ID(s)
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Fabry-Eyes-13
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RH-F-2013
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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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