Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis

Astellas

Status and phase: Terminated; Phase 2

Conditions: Aspergillosis

Treatments: Drug: Liposomal Amphotericin B; Drug: Micafungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00047827

FG463-21-11

01-0-125

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Have proven or probable systemic infection with Aspergillus species and have received no more than 96 hours of prior therapeutic doses of systemic antifungal therapy

Exclusion Criteria

• Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
• Has allergic bronchopulmonary aspergillosis, aspergillomas, or with sinus aspergillosis or external otitis who do not have evidence of tissue invasion
• Has life expectancy of less than five days

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Liposomal Amphotericin B

Drug: Micafungin