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| Name | Class |
|---|---|
| Astellas Pharma Korea, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSCT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin | Drug | i.v. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | at day 100 | |
| Safety assessed by lab-test and adverse events | during micafungin prophylaxis therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Administration Dept. | Contact | clinicaltrials_info@jp.astellas.com |
| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recruiting | Busan | South Korea | ||||
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| Recruiting |
| Daegu |
| South Korea |
| Recruiting | Daejeon | South Korea |
| Recruiting | Goyang | South Korea |
| Recruiting | Hwasun | South Korea |
| Recruiting | Seoul | South Korea |
| Recruiting | Suwon | South Korea |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
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