Status:
UNKNOWN
Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Astellas Pharma Korea, Inc.
Conditions:
Neutropenia
Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
Up to 19 years
Phase:
PHASE4
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 treatmen...
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 mic...
Eligibility Criteria
Inclusion
- Patients will receive allogeneic hematopoietic stem cell transplantation
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT01135589
Start Date
April 1 2010
End Date
May 1 2012
Last Update
September 28 2010
Active Locations (7)
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1
Busan, South Korea
2
Daegu, South Korea
3
Daejeon, South Korea
4
Goyang, South Korea