- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00606268
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
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90027
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Orange, California, United States, 92868
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Palo Alto, California, United States, 94304
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Colorado
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Denver, Colorado, United States, 80218
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Illinois
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Chicago, Illinois, United States, 60614
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Indiana
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Indianapolis, Indiana, United States, 46202
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Minnesota
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Minneapolis, Minnesota, United States, 55255
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New York
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Rochester, New York, United States, 14642
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
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Tennessee
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Memphis, Tennessee, United States, 38105
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Texas
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Houston, Texas, United States, 77030
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Virginia
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Richmond, Virginia, United States, 23219
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
1.0 mg/kg
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IV
Other Names:
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Experimental: 2
1.5 mg/kg
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IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Plasma drug concentration parameters: AUC0-24, Cmax
Time Frame: 13-17 Days
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13-17 Days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Adverse events, vital signs, ECGs and laboratory test values
Time Frame: Day 1 to End of study
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Day 1 to End of study
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Central Contact, Astellas Pharma Global Development
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9463-CL-2103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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