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

A Phase 2, Open-Label, Non-Comparative Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) as First-Line Therapy in the Treatment of Invasive Aspergillosis

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00047827

Enrollment

Registered

2002-10-24

Start date

2002-12-31

Completion date

2003-02-28

Last updated

2014-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspergillosis

Keywords

Aspergillus, Aspergillosis, Anti-Fungal, AmBisome, Micafungin

Brief summary

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.

Interventions

DRUGMicafungin

DRUGLiposomal Amphotericin B

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of treatment response defined as complete or partial response	Day 28, end of combined therapy and Day 84

Secondary

Measure	Time frame
Clinical Response	Day 28, end of combined therapy and Day 84
Radiological Response	Day 28, end of combined therapy and Day 84
Mycological Response	Day 28, end of combined therapy and Day 84
Survival at Day 84	Day 84

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026