Overview

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

Status:
Unknown status
Trial end date:
2012-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asan Medical Center
Collaborator:
Astellas Pharma Korea, Inc.
Treatments:
Echinocandins
Micafungin
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