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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00606268 |
The study will evaluate PK and safety of two dose levels of Micafungin (FK463) as Antifungal prophylaxis in children and adolescents undergoing HSCT
Condition | Intervention | Phase |
---|---|---|
Fungal Infections |
Drug: Micafungin |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin as an Antifungal Prophylaxis in Children and Adolescents Undergoing Hematopoietic Stem Cell Transplant |
Enrollment: | 42 |
Study Start Date: | November 2007 |
Study Completion Date: | March 2009 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
1.0 mg/kg
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Drug: Micafungin
IV
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2: Experimental
1.5 mg/kg
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Drug: Micafungin
IV
|
This is a prospective, multi-center, open-label, repeat-dose pharmacokinetic study that contains two treatment (micafungin 1.0mg/kg and 1.5mg/kg) dose groups. Subjects will be enrolled according to age and stratified by weight to receive either 1.0mg/kg (weight > 25kg) or 1.5mg/kg ( weight < 25kg) micafungin.
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
Ages Eligible for Study: | 4 Months to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Orange, California, United States, 92868 | |
Palo Alto, California, United States, 94304 | |
Los Angeles, California, United States, 90027 | |
United States, Colorado | |
Denver, Colorado, United States, 80218 | |
United States, Illinois | |
Chicago, Illinois, United States, 60614 | |
United States, Indiana | |
Indianapolis, Indiana, United States, 46202 | |
United States, Minnesota | |
Minneapolis, Minnesota, United States, 55255 | |
United States, New York | |
Rochester, New York, United States, 14642 | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Tennessee | |
Memphis, Tennessee, United States, 38105 | |
United States, Texas | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Richmond, Virginia, United States, 23219 |
Study Director: | Central Contact | Astellas Pharma Global Development |
Responsible Party: | Astellas Pharma Global Development ( Sr Manager Clinical Trial Registry ) |
Study ID Numbers: | 9463-CL-2103 |
Study First Received: | January 21, 2008 |
Last Updated: | April 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00606268 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antifungal Prophylaxis Hematopoietic Stem Cell Transplant HSCT Micafungin |
Anti-Infective Agents Mycoses Antifungal Agents Micafungin |
Anti-Infective Agents Mycoses Therapeutic Uses Antifungal Agents |
Infection Pharmacologic Actions Micafungin |