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