CLINICAL TRIALS PROFILE FOR MICAFUNGIN IN SODIUM CHLORIDE 0.9%

505(b)(2) Clinical Trials for Micafungin In Sodium Chloride 0.9%

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Institutul Clinic Fundeni	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Institutul Clinic Fundeni Bucharest	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage	NCT02372357 ↗	A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area	Completed	Universitaire Ziekenhuizen Leuven	Phase 4	2012-02-01	A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.

All Clinical Trials for Micafungin In Sodium Chloride 0.9%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00047827 ↗	Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis	Terminated	Astellas Pharma Inc	Phase 2	2002-12-01	The purpose of this study is to evaluate the safety and effectiveness of micafungin in combination with AmBisome as first-line therapy in the treatment of invasive aspergillosis.
NCT00048750 ↗	Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU	Terminated	Astellas Pharma Inc	Phase 3	2003-01-01	The purpose of this study is to determine the efficacy and safety of intravenous micafungin versus placebo as prophylactic therapy for invasive fungal infections in patients in the intensive care unit considered to be at high risk.
NCT00105144 ↗	Study of Micafungin in Patients With Invasive Candidiasis or Candidemia	Completed	Astellas Pharma Inc	Phase 3	2004-09-01	The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.
NCT00106288 ↗	Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia	Completed	Astellas Pharma Inc	Phase 3	2003-01-01	The purpose of this study is to determine the efficacy and safety of micafungin (FK463) versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or candidemia. Enrollment will include adult and pediatric patients.
NCT00189709 ↗	Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia	Completed	Astellas Pharma Taiwan, Inc.	Phase 3	2004-08-01	To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia
NCT00189709 ↗	Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia	Completed	Astellas Pharma Inc	Phase 3	2004-08-01	To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia

Clinical Trial Conditions for Micafungin In Sodium Chloride 0.9%

Condition Name

Condition Name for Micafungin In Sodium Chloride 0.9%
Intervention	Trials
Candidemia	8
Invasive Candidiasis	7
Candidiasis	7
Aspergillosis	3

Condition MeSH

Condition MeSH for Micafungin In Sodium Chloride 0.9%
Intervention	Trials
Candidiasis	21
Mycoses	20
Candidiasis, Invasive	14
Invasive Fungal Infections	11

Clinical Trial Locations for Micafungin In Sodium Chloride 0.9%

Trials by Country

Trials by Country for Micafungin In Sodium Chloride 0.9%
Location	Trials
United States	183
Canada	22
Brazil	12
France	10
Spain	8

Trials by US State

Trials by US State for Micafungin In Sodium Chloride 0.9%
Location	Trials
Texas	13
North Carolina	12
California	11
Pennsylvania	8
New York	8

Clinical Trial Progress for Micafungin In Sodium Chloride 0.9%

Clinical Trial Phase

Clinical Trial Phase for Micafungin In Sodium Chloride 0.9%
Clinical Trial Phase	Trials
Phase 4	18
Phase 3	12
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Micafungin In Sodium Chloride 0.9%
Clinical Trial Phase	Trials
Completed	35
Terminated	12
Unknown status	4

Clinical Trial Sponsors for Micafungin In Sodium Chloride 0.9%

Sponsor Name

Sponsor Name for Micafungin In Sodium Chloride 0.9%
Sponsor	Trials
Astellas Pharma Inc	20
Astellas Pharma China, Inc.	4
Astellas Pharma US, Inc.	3

Sponsor Type

Sponsor Type for Micafungin In Sodium Chloride 0.9%
Sponsor	Trials
Industry	38
Other	35
NIH	4