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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00606268
Collaborator
(none)
42
Enrollment
12
Locations
2
Arms
16
Duration (Months)
3.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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 Start Date :
Nov 1, 2007
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

1.0 mg/kg

Drug: Micafungin
IV
Other Names:
  • FK463

    		•
    Experimental: 2

    1.5 mg/kg

    Drug: Micafungin
    IV
    Other Names:
  • FK463

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma drug concentration parameters: AUC0-24, Cmax [13-17 Days]

    Secondary Outcome Measures

    1. Adverse events, vital signs, ECGs and laboratory test values [Day 1 to End of study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Months to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Los Angeles California United States 90027
    2 Orange California United States 92868
    3 Palo Alto California United States 94304
    4 Denver Colorado United States 80218
    5 Chicago Illinois United States 60614
    6 Indianapolis Indiana United States 46202
    7 Minneapolis Minnesota United States 55255
    8 Rochester New York United States 14642
    9 Philadelphia Pennsylvania United States 19104
    10 Memphis Tennessee United States 38105
    11 Houston Texas United States 77030
    12 Richmond Virginia United States 23219

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Director: Central Contact, Astellas Pharma Global Development

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT00606268
    Other Study ID Numbers:
    • 9463-CL-2103
    First Posted:
    Feb 1, 2008
    Last Update Posted:
    Aug 21, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by Astellas Pharma Inc
    Antifungal Prophylaxis
    Hematopoietic Stem Cell Transplant
    HSCT
    Micafungin
    Additional relevant MeSH terms:
    Mycoses
    Micafungin

    Study Results

    No Results Posted as of Aug 21, 2014