Study Stopped
Inadequate enrollment
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
2 other identifiers
interventional
2
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2002
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2002
CompletedFirst Posted
Study publicly available on registry
October 24, 2002
CompletedStudy Start
First participant enrolled
December 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedAugust 20, 2014
August 1, 2014
2 months
October 18, 2002
August 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of treatment response defined as complete or partial response
Day 28, end of combined therapy and Day 84
Secondary Outcomes (4)
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
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
Detroit, Michigan, 48201, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Memphis, Tennessee, 38105, United States
Unknown Facility
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2002
First Posted
October 24, 2002
Study Start
December 1, 2002
Primary Completion
February 1, 2003
Study Completion
February 1, 2003
Last Updated
August 20, 2014
Record last verified: 2014-08