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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01135589
First received: May 25, 2010
Last updated: September 27, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Neutropenia
Hematopoietic Stem Cell Transplantation
Invasive Fungal Disease
Drug: Micafungin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival rate [ Time Frame: at day 100 ] [ Designated as safety issue: No ]
  • Safety assessed by lab-test and adverse events [ Time Frame: during micafungin prophylaxis therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 145
Study Start Date: April 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HSCT Drug: Micafungin
i.v.
Other Names:
  • FK463
  • Fungard

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.

  Eligibility

Ages Eligible for Study:   up to 19 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01135589

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

Locations
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
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01135589     History of Changes
Other Study ID Numbers: KSPHO 2010-02
Study First Received: May 25, 2010
Last Updated: September 27, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
pediatric
adolescent
micafungin

Additional relevant MeSH terms:
Mycoses
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Micafungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014