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

NCT ID: NCT01135589

Last Updated: 2010-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Neutropenia Hematopoietic Stem Cell Transplantation Invasive Fungal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HSCT

Group Type EXPERIMENTAL

Micafungin

Intervention Type DRUG

i.v.

Interventions

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Micafungin

i.v.

Intervention Type DRUG

Other Intervention Names

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FK463 Fungard

Eligibility Criteria

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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
Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Korea, Inc.

INDUSTRY

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Astellas Pharma, Inc

Principal Investigators

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Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Busan, , South Korea

Site Status RECRUITING

Daegu, , South Korea

Site Status RECRUITING

Daejeon, , South Korea

Site Status RECRUITING

Goyang, , South Korea

Site Status RECRUITING

Hwasun, , South Korea

Site Status RECRUITING

Seoul, , South Korea

Site Status RECRUITING

Suwon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Clinical Development Administration Dept.

Role: CONTACT

[email protected]

Other Identifiers

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KSPHO 2010-02

Identifier Type: -

Identifier Source: org_study_id