NCT00606268

A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 4 Months – 16 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate PK and safety of two dose levels of Micafungin (FK463) as Antifungal prophylaxis in children and adolescents undergoing HSCT

Detailed description

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

Conditions

• Fungal Infections

Interventions

Type	Name	Description
DRUG	Micafungin	IV

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-02-01
• Last updated: 2014-08-21

Locations

12 sites across 1 country: United States