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

August 19, 2014 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90027
      • Orange, California, United States, 92868
      • Palo Alto, California, United States, 94304
    • Colorado
      • Denver, Colorado, United States, 80218
    • Illinois
      • Chicago, Illinois, United States, 60614
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Minnesota
      • Minneapolis, Minnesota, United States, 55255
    • New York
      • Rochester, New York, United States, 14642
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Tennessee
      • Memphis, Tennessee, United States, 38105
    • Texas
      • Houston, Texas, United States, 77030
    • Virginia
      • Richmond, Virginia, United States, 23219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: 1
1.0 mg/kg
IV
Other Names:
  • FK463
Experimental: 2
1.5 mg/kg
IV
Other Names:
  • FK463

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma drug concentration parameters: AUC0-24, Cmax
Time Frame: 13-17 Days
13-17 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events, vital signs, ECGs and laboratory test values
Time Frame: Day 1 to End of study
Day 1 to End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Central Contact, Astellas Pharma Global Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 21, 2008

First Submitted That Met QC Criteria

January 31, 2008

First Posted (Estimate)

February 1, 2008

Study Record Updates

Last Update Posted (Estimate)

August 21, 2014

Last Update Submitted That Met QC Criteria

August 19, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

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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