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

Neutropenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01135589
• Other study ID #: KSPHO 2010-02
• Status: Recruiting
• Phase: Phase 4
• First received: May 25, 2010
• Last updated: September 27, 2010
• Start date: April 2010
• Est. completion date: May 2012

Study information

• Verified date: June 2010
• Source: Asan Medical Center
• Contact: Clinical Development Administration Dept.
• Email: clinicaltrials_info[@]jp.astellas.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 19 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplantation
• Invasive Fungal Disease
• Mycoses
• Neutropenia

Intervention

Drug:
• Micafungin
i.v.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence rate of IFDs assessed by physical examination and serum galactomannan test		during micafungin prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis	No
Secondary	Survival rate		at day 100	No
Secondary	Safety assessed by lab-test and adverse events		during micafungin prophylaxis therapy	No