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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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12 December 2020 |
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Main ID: |
NCT00036166 |
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Date of registration:
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08/05/2002 |
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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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Study of FK463 for the Treatment of Invasive Aspergillosis
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Scientific title:
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An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis |
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Date of first enrolment:
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January 29, 1999 |
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Target sample size:
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326 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00036166 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Austria
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France
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Germany
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Italy
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Poland
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Spain
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Sweden
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion Criteria
- Has proven or probable systemic infection with Aspergillus species
Exclusion Criteria
- Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
- Has bronchopulmonary aspergillosis, aspergillomas, sinus aspergillosis or external
otitis but does not have histologic evidence of tissue invasion
- Has life-expectancy judged to be less than 5 days
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Aspergillosis
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Intervention(s)
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Drug: FK463
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Secondary ID(s)
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FG463-21-01
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98-0-046
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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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