- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01135589
Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation
September 27, 2010 updated by: Asan Medical Center
Efficacy and Safety in Micafungin Sodium for Prophylaxis Against Invasive Fungal Disease During Neutropenia in Pediatric & Adolescent Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
145
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
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
- Recruiting
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HSCT
|
i.v.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
during micafungin prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival rate
Time Frame: at day 100
|
at day 100
|
Safety assessed by lab-test and adverse events
Time Frame: during micafungin prophylaxis therapy
|
during micafungin prophylaxis therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Anticipated)
May 1, 2012
Study Completion (Anticipated)
May 1, 2012
Study Registration Dates
First Submitted
May 25, 2010
First Submitted That Met QC Criteria
June 2, 2010
First Posted (Estimate)
June 3, 2010
Study Record Updates
Last Update Posted (Estimate)
September 28, 2010
Last Update Submitted That Met QC Criteria
September 27, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSPHO 2010-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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