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

Aspergillosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00047827
• Other study ID #: 01-0-125
• Secondary ID: FG463-21-11
• Status: Terminated
• Phase: Phase 2
• First received: October 18, 2002
• Last updated: August 19, 2014
• Start date: December 2002
• Est. completion date: February 2003

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 2003
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspergillosis

Intervention

Drug:
• Micafungin
IV
• Liposomal Amphotericin B
IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment response defined as complete or partial response		Day 28, end of combined therapy and Day 84	No
Secondary	Clinical Response		Day 28, end of combined therapy and Day 84	No
Secondary	Radiological Response		Day 28, end of combined therapy and Day 84	No
Secondary	Mycological Response		Day 28, end of combined therapy and Day 84	No
Secondary	Survival at Day 84		Day 84	No

External Links

•   Link to Results on JAPIC - enter 140538 in the JapicCTI-RNo. field