Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fungal Infections
Keywords: Antifungal Prophylaxis
Hematopoietic Stem Cell Transplant
HSCT
Micafungin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-02-01
Enrollment: 42
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: Inclusion Criteria:

* Institutional Review Board (IRB)-approved written informed Consent / Assent (as applicable) and HIPAA Authorization must be obtained from the subject (as able) and /or subject's parent/legally authorized representative prior to any study-related procedures
* 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 evidence of significant liver disease as defined by aspartate transamine (AST/SGOT), alanine transaminases (ALT/SGPT) 10 times the upper limit of normal (ULN) and total bilirubin or alkaline phosphatase \> 5 times the ULN
* 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

Primary outcomes:
measure: Plasma drug concentration parameters: AUC0-24, Cmax
timeFrame: 13-17 Days
Secondary outcomes:
measure: Adverse events, vital signs, ECGs and laboratory test values
timeFrame: Day 1 to End of study
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Minneapolis
country: United States
state: Minnesota
city: Rochester
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Astellas Pharma Global Development
name: Central Contact
role: STUDY_DIRECTOR
References: