Back to resultsA Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant
Primary Purpose
Fungal Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Micafungin
Sponsored by
About this trial
This is an interventional prevention trial for Fungal Infections focused on measuring Antifungal Prophylaxis, Hematopoietic Stem Cell Transplant, HSCT, Micafungin
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
1.0 mg/kg
1.5 mg/kg
Outcomes
Primary Outcome Measures
Plasma drug concentration parameters: AUC0-24, Cmax
Secondary Outcome Measures
Adverse events, vital signs, ECGs and laboratory test values
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00606268
Brief Title
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
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Infections
Keywords
Antifungal Prophylaxis, Hematopoietic Stem Cell Transplant, HSCT, Micafungin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
1.0 mg/kg
Arm Title
2
Arm Type
Experimental
Arm Description
1.5 mg/kg
Intervention Type
Drug
Intervention Name(s)
Micafungin
Other Intervention Name(s)
FK463
Intervention Description
IV
Primary Outcome Measure Information:
Title
Plasma drug concentration parameters: AUC0-24, Cmax
Time Frame
13-17 Days
Secondary Outcome Measure Information:
Title
Adverse events, vital signs, ECGs and laboratory test values
Time Frame
Day 1 to End of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55255
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140541 in the JapicCTI-RNo. field
Learn more about this trial
A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant
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