| January 23, 2008 |
| September 2, 2009 |
| October 2007 |
| October 2009 (final data collection date for primary outcome measure) |
| Evaluation of Micafungin pharmacokinetics [ Time Frame: 10 - 14 Days ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00607763 on ClinicalTrials.gov Archive Site |
| Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECGs and physical evaluation [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ] |
| Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECTs and physical evaluation [ Time Frame: 13 - 17 Days ] [ Designated as safety issue: No ] |
| |
| Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug |
| A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Infants And Toddlers (≥4 Months TO < 24 Months Of Age) With Esophageal Candidiasis Or Other Invasive Candidiasis |
Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an antifungal drug. Safety and drug blood levels will be assessed |
This is a prospective, multicenter, open-label, repeat-dose study. Subjects will receive treatment with intravenous micafungin for 10 to 14 days (per investigator clinical judgment) at a daily dose of 4.5 mg/kg (determined by the subject's weight at baseline). Serial blood samples for assessment of pharmacokinetics will be collected. |
| Phase I |
| Interventional |
| Other, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
- Invasive Candidiasis
- Esophageal Candidiasis
- Oropharyngeal Candidiasis
- Candidemia
|
| Drug: Micafungin |
| |
| |
| |
| Recruiting |
| 8 |
| October 2009 |
| October 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Subject is ≥4 months to < 24 months
- Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis
- Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables
Exclusion Criteria:
- Subject has evidence of significant liver disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), bilirubin or alkaline phosphatase > 5 times the upper limit of normal (ULN)
- Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study
- Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
- Subject has received treatment with an echinocandin within one week prior to first dosing
- Subject status is unstable and subject is unlikely to complete all study required procedures
|
| Both |
| 4 Months to 23 Months |
| No |
|
|
| United States |
| |
| NCT00607763 |
| Sr Manager Clinical Trial Registry, Astellas Pharma Global Development |
| 9463-CL-2102 |
| Astellas Pharma Inc |
|
| Study Director: |
Central Contact |
Astellas Pharma Global Development |
|
|
| Astellas Pharma Inc |
| September 2009 |
