|
|
|
|
|
|
Sponsored by: |
Astellas Pharma Inc |
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 |
MedlinePlus related topics: | Fungal Infections |
Drug Information available for: | Clotrimazole Miconazole Miconazole nitrate Tioconazole Micafungin FK 463 |
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 |
Estimated Enrollment: | 32 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
1.0 mg/kg
|
Drug: Micafungin
IV
|
2: Experimental
1.5 mg/kg
|
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:
Contact: Astellas Pharm US Medical Information | 800-888-7704 ext 5473 | clintrials.info@us.astellas.com |
United States, California | |||||
Recruiting | |||||
Orange, California, United States, 92868 | |||||
Withdrawn | |||||
Los Angeles, California, United States, 90024 | |||||
Recruiting | |||||
Palo Alto, California, United States, 94304 | |||||
Recruiting | |||||
Los Angeles, California, United States, 90027 | |||||
United States, Colorado | |||||
Recruiting | |||||
Denver, Colorado, United States, 80218 | |||||
United States, Illinois | |||||
Recruiting | |||||
Chicago, Illinois, United States, 60614 | |||||
United States, Indiana | |||||
Recruiting | |||||
Indianapolis, Indiana, United States, 46202 | |||||
United States, Minnesota | |||||
Withdrawn | |||||
Rochester, Minnesota, United States, 55905 | |||||
Active, not recruiting | |||||
Minneapolis, Minnesota, United States, 55255 | |||||
United States, New York | |||||
Recruiting | |||||
Rochester, New York, United States, 14642 | |||||
United States, Pennsylvania | |||||
Recruiting | |||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
United States, Tennessee | |||||
Recruiting | |||||
Memphis, Tennessee, United States, 38105 | |||||
United States, Texas | |||||
Recruiting | |||||
Houston, Texas, United States, 77030 | |||||
United States, Virginia | |||||
Recruiting | |||||
Richmond, Virginia, United States, 23219 |
Astellas Pharma Inc |
Study Director: | Central Contact | Astellas Pharma US, Inc. |
Responsible Party: | Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry ) |
Study ID Numbers: | 9463-CL-2103 |
First Received: | January 21, 2008 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00606268 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|