Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aspergillosis
Intervention: Micafungin (Drug); Liposomal Amphotericin B (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Incidence of treatment response defined as complete or partial response
Secondary outcome: Clinical ResponseRadiological Response Mycological Response Survival at Day 84
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Washington, District of Columbia 20010, United States
Atlanta, Georgia 30322, United States
Detroit, Michigan 48201, United States
Ann Arbor, Michigan 48109, United States
St. Louis, Missouri 63110, United States
Memphis, Tennessee 38105, United States
Houston, Texas 77030, United States
Additional Information
Click here for more information about the sponsor: Fujisawa Healthcare, Inc.
Starting date: December 2002
Ending date: February 2003
Last updated: March 29, 2008
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