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

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ClinicalTrials.gov Identifier: NCT01135589
Recruitment Status : Unknown
Verified June 2010 by Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : June 3, 2010
Last Update Posted : September 28, 2010
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by:
Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Neutropenia Hematopoietic Stem Cell Transplantation Invasive Fungal Disease Drug: Micafungin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : April 2010
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012


Arm Intervention/treatment
Experimental: HSCT Drug: Micafungin
i.v.
Other Names:
  • FK463
  • Fungard




Primary Outcome Measures :
  1. 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 Measures :
  1. Survival rate [ Time Frame: at day 100 ]
  2. Safety assessed by lab-test and adverse events [ Time Frame: during micafungin prophylaxis therapy ]


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Ages Eligible for Study:   up to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135589


Contacts
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Contact: Clinical Development Administration Dept. clinicaltrials_info@jp.astellas.com

Locations
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Korea, Republic of
Recruiting
Busan, Korea, Republic of
Recruiting
Daegu, Korea, Republic of
Recruiting
Daejeon, Korea, Republic of
Recruiting
Goyang, Korea, Republic of
Recruiting
Hwasun, Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Recruiting
Suwon, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Astellas Pharma Korea, Inc.
Investigators
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Study Chair: Use Central Contact Astellas Pharma Inc

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Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01135589     History of Changes
Other Study ID Numbers: KSPHO 2010-02
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: September 28, 2010
Last Verified: June 2010
Keywords provided by Asan Medical Center:
pediatric
adolescent
micafungin
Additional relevant MeSH terms:
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Mycoses
Invasive Fungal Infections
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Micafungin
Antifungal Agents
Anti-Infective Agents