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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00606268
Recruitment Status : Completed
First Posted : February 1, 2008
Last Update Posted : August 21, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

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
Fungal Infections Drug: Micafungin 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

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Study Type : Interventional  (Clinical Trial)
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 : November 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
1.0 mg/kg
Drug: Micafungin
Other Name: FK463

Experimental: 2
1.5 mg/kg
Drug: Micafungin
Other Name: FK463

Primary Outcome Measures :
  1. Plasma drug concentration parameters: AUC0-24, Cmax [ Time Frame: 13-17 Days ]

Secondary Outcome Measures :
  1. Adverse events, vital signs, ECGs and laboratory test values [ Time Frame: Day 1 to End of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 16 Years   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00606268

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United States, California
Los Angeles, California, United States, 90027
Orange, California, United States, 92868
Palo Alto, California, United States, 94304
United States, Colorado
Denver, Colorado, United States, 80218
United States, Illinois
Chicago, Illinois, United States, 60614
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Minneapolis, Minnesota, United States, 55255
United States, New York
Rochester, New York, United States, 14642
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Memphis, Tennessee, United States, 38105
United States, Texas
Houston, Texas, United States, 77030
United States, Virginia
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Astellas Pharma Inc
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Study Director: Central Contact Astellas Pharma Global Development
Additional Information:
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Responsible Party: Astellas Pharma Inc Identifier: NCT00606268    
Other Study ID Numbers: 9463-CL-2103
First Posted: February 1, 2008    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014
Keywords provided by Astellas Pharma Inc:
Antifungal Prophylaxis
Hematopoietic Stem Cell Transplant
Additional relevant MeSH terms:
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Antifungal Agents
Anti-Infective Agents