A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant
NCT ID: NCT00606268
Last Updated: 2014-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2007-11-30
2009-03-31
Brief Summary
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Detailed Description
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Children (4 months to \< 2years, 2 to 5 years and 6 to 11 years) and adolescents (12 to 16 years) undergoing HSCT who require antifungal prophylaxis will be enrolled
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
1.0 mg/kg
Micafungin
IV
2
1.5 mg/kg
Micafungin
IV
Interventions
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Micafungin
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has sufficient venous access to permit administration of study drug, collect pharmacokinetic samples and monitor laboratory safety variables
* Female subject of childbearing potential must have a negative pregnancy test within 72 hours prior to the first dose of study drug, and if sexually active agree method of birth control per Investigator judgment for the duration of the study
* Subject (when able) and /or subjects parent/legally authorized representative agree to comply with the study requirements and with the concomitant medication restrictions
* Subject plans to undergo a HSCT
Exclusion Criteria
* Subject has concomitant medical condition that in the opinion of the Investigator and /or medical monitor precludes enrollment into the study
* Subject with evidence of an active systemic or disseminated fungal infection prior to enrollment
* Subject has a history of anaphylaxis, hypersensitivity, or any serious reactions to the echinocandin class of antifungals
* Subject had received treatment with an echinocandin within one week prior to first dose of study drug
* Subject status is unstable and subject is unlikely to complete required study procedures
* Female subject is pregnant or nursing. Females of childbearing potential must avoid becoming pregnant while receiving study drug
4 Months
16 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Los Angeles, California, United States
Orange, California, United States
Palo Alto, California, United States
Denver, Colorado, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Minneapolis, Minnesota, United States
Rochester, New York, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Richmond, Virginia, United States
Countries
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Other Identifiers
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9463-CL-2103
Identifier Type: -
Identifier Source: org_study_id
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