A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00606268
First received: January 21, 2008
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

The study will evaluate PK and safety of two dose levels of Micafungin (FK463) as Antifungal prophylaxis in children and adolescents undergoing HSCT


Condition Intervention Phase
Fungal Infections
Drug: Micafungin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Plasma drug concentration parameters: AUC0-24, Cmax [ Time Frame: 13-17 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events, vital signs, ECGs and laboratory test values [ Time Frame: Day 1 to End of study ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: November 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1.0 mg/kg
Drug: Micafungin
IV
Other Name: FK463
Experimental: 2
1.5 mg/kg
Drug: Micafungin
IV
Other Name: FK463

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

Ages Eligible for Study:   4 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606268

Locations
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
Investigators
Study Director: Central Contact Astellas Pharma Global Development
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00606268     History of Changes
Other Study ID Numbers: 9463-CL-2103
Study First Received: January 21, 2008
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Antifungal Prophylaxis
Hematopoietic Stem Cell Transplant
HSCT
Micafungin

Additional relevant MeSH terms:
Mycoses
Micafungin
Miconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014