A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fungal Infections
Intervention: Micafungin (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.
Overall contact:
Astellas Pharm US Medical Information, Phone: 800-888-7704, Ext: 5473, Email: clintrials.info@us.astellas.com
Summary
The study will evaluate PK and safety of two dose levels of Micafungin (FK463) as Antifungal
prophylaxis in children and adolescents undergoing HSCT
Clinical Details
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 design: Prevention, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Plasma drug concentration parameters: AUC0-24, Cmax
Secondary outcome: Adverse events, vital signs, ECGs and laboratory test values
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
Minimum age: 4 Months.
Maximum age: 16 Years.
Gender(s): Both.
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
Locations and Contacts
Astellas Pharm US Medical Information, Phone: 800-888-7704, Ext: 5473, Email: clintrials.info@us.astellas.com
Orange, California 92868, United States; Recruiting
Los Angeles, California 90024, United States; Withdrawn
Palo Alto, California 94304, United States; Recruiting
Los Angeles, California 90027, United States; Recruiting
Denver, Colorado 80218, United States; Recruiting
Chicago, Illinois 60614, United States; Recruiting
Indianapolis, Indiana 46202, United States; Recruiting
Rochester, Minnesota 55905, United States; Withdrawn
Minneapolis, Minnesota 55255, United States; Active, not recruiting
Rochester, New York 14642, United States; Recruiting
Philadelphia, Pennsylvania 19104, United States; Recruiting
Memphis, Tennessee 38105, United States; Recruiting
Houston, Texas 77030, United States; Recruiting
Richmond, Virginia 23219, United States; Recruiting
Additional Information
Starting date: November 2007
Ending date: October 2008
Last updated: September 17, 2008
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