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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

This study is currently recruiting participants.
Verified by Astellas Pharma Inc, September 2008

Sponsored by: Astellas Pharma Inc
Information provided by: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00606268
  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 I

MedlinePlus related topics:   Fungal Infections   

Drug Information available for:   Clotrimazole    Miconazole    Miconazole nitrate    Tioconazole    Micafungin    FK 463   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
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

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 ]

Estimated Enrollment:   32
Study Start Date:   November 2007
Estimated Study Completion Date:   October 2008
Estimated Primary Completion Date:   October 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
1.0 mg/kg
Drug: Micafungin
IV
2: Experimental
1.5 mg/kg
Drug: Micafungin
IV

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

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

Contacts
Contact: Astellas Pharm US Medical Information     800-888-7704 ext 5473     clintrials.info@us.astellas.com    

Locations
United States, California
Recruiting
      Orange, California, United States, 92868
Withdrawn
      Los Angeles, California, United States, 90024
Recruiting
      Palo Alto, California, United States, 94304
Recruiting
      Los Angeles, California, United States, 90027
United States, Colorado
Recruiting
      Denver, Colorado, United States, 80218
United States, Illinois
Recruiting
      Chicago, Illinois, United States, 60614
United States, Indiana
Recruiting
      Indianapolis, Indiana, United States, 46202
United States, Minnesota
Withdrawn
      Rochester, Minnesota, United States, 55905
Active, not recruiting
      Minneapolis, Minnesota, United States, 55255
United States, New York
Recruiting
      Rochester, New York, United States, 14642
United States, Pennsylvania
Recruiting
      Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Recruiting
      Memphis, Tennessee, United States, 38105
United States, Texas
Recruiting
      Houston, Texas, United States, 77030
United States, Virginia
Recruiting
      Richmond, Virginia, United States, 23219

Sponsors and Collaborators
Astellas Pharma Inc

Investigators
Study Director:     Central Contact     Astellas Pharma US, Inc.    
  More Information


Responsible Party:   Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry )
Study ID Numbers:   9463-CL-2103
First Received:   January 21, 2008
Last Updated:   September 17, 2008
ClinicalTrials.gov Identifier:   NCT00606268
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Mycoses
Clotrimazole
Miconazole
Tioconazole
Micafungin

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Infective Agents, Local
Antifungal Agents
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008




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