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Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation

Primary Purpose

Neutropenia, Hematopoietic Stem Cell Transplantation, Invasive Fungal Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Micafungin
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neutropenia focused on measuring pediatric, adolescent, micafungin

Eligibility Criteria

undefined - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients will receive allogeneic hematopoietic stem cell transplantation

Exclusion Criteria:

  • Aspartate transaminase or alanine transaminase level > 5 times UNL
  • Bilirubin > 2. 5 times UNL
  • History of allergy, sensitivity, or any serious reaction to an echinocandin
  • Invasive fungal disease at the time of enrolment
  • Systemic antifungal therapy within 72 hrs before administration of the first dose of study drug
  • Positive pregnancy test

Sites / Locations

  • Recruiting
  • Recruiting
  • Recruiting
  • Recruiting
  • Recruiting
  • Recruiting
  • Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HSCT

Arm Description

Outcomes

Primary Outcome Measures

Absence rate of IFDs assessed by physical examination and serum galactomannan test

Secondary Outcome Measures

Survival rate
Safety assessed by lab-test and adverse events

Full Information

First Posted
May 25, 2010
Last Updated
September 27, 2010
Sponsor
Asan Medical Center
Collaborators
Astellas Pharma Korea, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01135589
Brief Title
Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation
Official Title
Efficacy and Safety in Micafungin Sodium for Prophylaxis Against Invasive Fungal Disease During Neutropenia in Pediatric & Adolescent Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Asan Medical Center
Collaborators
Astellas Pharma Korea, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.
Detailed Description
The purpose of this study is to evaluate absence of proven, probable, possible, suspected invasive fungal disease (IFDs) through the end of prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis after allogeneic hematopoietic stem cell transplantation in pediatric and adolescent neutropenia patients. Patients will receive micafungin until the earliest of the following: 1) neutrophil engraftment; 2) development of proven, provable, possible or suspected invasive fungal disease; 3) development of unacceptable drug toxicity; 4) withdrawal from study participation or discontinuation of study treatment. Safety profile of micafungin is also evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia, Hematopoietic Stem Cell Transplantation, Invasive Fungal Disease
Keywords
pediatric, adolescent, micafungin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HSCT
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Micafungin
Other Intervention Name(s)
FK463, Fungard
Intervention Description
i.v.
Primary Outcome Measure Information:
Title
Absence rate of IFDs assessed by physical examination and serum galactomannan test
Time Frame
during micafungin prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis
Secondary Outcome Measure Information:
Title
Survival rate
Time Frame
at day 100
Title
Safety assessed by lab-test and adverse events
Time Frame
during micafungin prophylaxis therapy

10. Eligibility

Sex
All
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will receive allogeneic hematopoietic stem cell transplantation Exclusion Criteria: Aspartate transaminase or alanine transaminase level > 5 times UNL Bilirubin > 2. 5 times UNL History of allergy, sensitivity, or any serious reaction to an echinocandin Invasive fungal disease at the time of enrolment Systemic antifungal therapy within 72 hrs before administration of the first dose of study drug Positive pregnancy test
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Development Administration Dept.
Email
clinicaltrials_info@jp.astellas.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
City
Goyang
Country
Korea, Republic of
Individual Site Status
Recruiting
City
Hwasun
Country
Korea, Republic of
Individual Site Status
Recruiting
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation

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