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

Fungal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606268
• Other study ID #: 9463-CL-2103
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2008
• Last updated: August 19, 2014
• Start date: November 2007
• Est. completion date: March 2009

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Months to 16 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fungal Infections
• Mycoses

Intervention

Drug:
• Micafungin
IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma drug concentration parameters: AUC0-24, Cmax		13-17 Days	No
Secondary	Adverse events, vital signs, ECGs and laboratory test values		Day 1 to End of study	No

External Links

•   Link to Results on JAPIC - enter 140541 in the JapicCTI-RNo. field