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

Phase 2

Terminated

• Conditions: Aspergillosis
• Interventions: Drug: Micafungin; Drug: Liposomal Amphotericin B

• Registration Number: NCT00047827
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-10-18
• Study First Submitted QC: 2002-10-23
• Study First Posted: 2002-10-24
• Study Start: 2002-12
• Primary Completion: 2003-02
• Study Completion: 2003-02
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Liposomal Amphotericin B	-
1	Micafungin	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Clinical Response	Day 28, end of combined therapy and Day 84