Back to resultsTrial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis
Primary Purpose
Aspergillosis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Micafungin
Liposomal Amphotericin B
Sponsored by
About this trial
This is an interventional treatment trial for Aspergillosis focused on measuring Aspergillus, Aspergillosis, Anti-Fungal, AmBisome, Micafungin
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Incidence of treatment response defined as complete or partial response
Secondary Outcome Measures
Clinical Response
Radiological Response
Mycological Response
Survival at Day 84
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00047827
Brief Title
Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Inadequate enrollment
Study Start Date
December 2002 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspergillosis
Keywords
Aspergillus, Aspergillosis, Anti-Fungal, AmBisome, Micafungin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Micafungin
Other Intervention Name(s)
Mycamine, FK463
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
Liposomal Amphotericin B
Other Intervention Name(s)
AmBisome
Intervention Description
IV
Primary Outcome Measure Information:
Title
Incidence of treatment response defined as complete or partial response
Time Frame
Day 28, end of combined therapy and Day 84
Secondary Outcome Measure Information:
Title
Clinical Response
Time Frame
Day 28, end of combined therapy and Day 84
Title
Radiological Response
Time Frame
Day 28, end of combined therapy and Day 84
Title
Mycological Response
Time Frame
Day 28, end of combined therapy and Day 84
Title
Survival at Day 84
Time Frame
Day 84
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140538 in the JapicCTI-RNo. field
Learn more about this trial
Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis
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