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Micafungin Prevention Study for Invasive Fungal Disease in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2014 by Seoul National University Hospital.
Recruitment status was  Recruiting
Information provided by:
Seoul National University Hospital Identifier:
First received: August 9, 2011
Last updated: July 11, 2014
Last verified: July 2014
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
Fungal Disease
Drug: micafungin
Phase 2

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 Autologous Hematopoietic Stem Cell Transplantation

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Absence rate of IFDs assessed by physical examination and serum galactomannan test [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Absence of proven, probable, possible invasive fungal disease (IFDs) through the end of prophylaxis therapy and during 4 weeks after stopping of Micafungin prophyalxis after HSCT

Secondary Outcome Measures:
  • Survival rate [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    IFD-related mortality

  • Safety assessed by lab-test and adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Safety profiles

Estimated Enrollment: 112
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Micafungin Drug: micafungin
Eligible patients who provided informed consent form will be administered micafungin at 50 mg/day (1mg/kg/day for patients weighting <50kg) as 1-h infusion. Infusion of Micafungin will be started on the day -2 of the conditioning course of autologous stem cell transplantation
Other Names:
  • Micafungin sodium
  • Mycamine

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 Autologous 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.

Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients will receive autologous hematopoietic stem cell transplantation including 2nd autologous transplantation
  2. Under 21 years old, pediatric, adolescent patients.

Exclusion Criteria:

  1. Aspartate transaminase or alanine transaminase level > 5 times UNL
  2. Bilirubin > 2.5 times UNL
  3. History of allergy, sensitivity, or any serious reaction to an echinocandin
  4. Invasive fungal disease at the time of enrolment
  5. Systemic antifungal therapy within 72 hrs before administration of the first dose of study drug
  6. 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 identifier: NCT01417169

Contact: Hyoung Jin Kang, M.D, Ph.D 82 2 2072 3304
Contact: Hyery Kim, M.D. 82 2 2072 0177

Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Chongno-gu, Korea, Republic of
Contact: Hyoung Jin Kang, M.D, Ph.D    82 2 2072 3304   
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Hyoung Jin Kang, M.D, Ph.D Seoul National University Hospital
  More Information Identifier: NCT01417169     History of Changes
Other Study ID Numbers: SNUCH-1102 
Study First Received: August 9, 2011
Last Updated: July 11, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Leukocyte Disorders
Hematologic Diseases
Antifungal Agents
Anti-Infective Agents processed this record on October 21, 2016