A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant
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
1 other identifier
interventional
42
1 country
12
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2007
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 21, 2008
CompletedFirst Posted
Study publicly available on registry
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedAugust 21, 2014
August 1, 2014
1.3 years
January 21, 2008
August 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma drug concentration parameters: AUC0-24, Cmax
13-17 Days
Secondary Outcomes (1)
Adverse events, vital signs, ECGs and laboratory test values
Day 1 to End of study
Study Arms (2)
1
EXPERIMENTAL1.0 mg/kg
2
EXPERIMENTAL1.5 mg/kg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Unknown Facility
Los Angeles, California, 90027, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Palo Alto, California, 94304, United States
Unknown Facility
Denver, Colorado, 80218, United States
Unknown Facility
Chicago, Illinois, 60614, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Minneapolis, Minnesota, 55255, United States
Unknown Facility
Rochester, New York, 14642, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Memphis, Tennessee, 38105, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Richmond, Virginia, 23219, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2008
First Posted
February 1, 2008
Study Start
November 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
August 21, 2014
Record last verified: 2014-08