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

This study has been terminated.
(Inadequate enrollment)
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00047827
First received: October 18, 2002
Last updated: September 29, 2008
Last verified: March 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Aspergillosis
 Drug: Micafungin
Drug: Liposomal Amphotericin B
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Aspergillosis
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of treatment response defined as complete or partial response [ Time Frame: Day 28, end of combined therapy and Day 84 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Response [ Time Frame: Day 28, end of combined therapy and Day 84 ] [ Designated as safety issue: No ]
  • Radiological Response [ Time Frame: Day 28, end of combined therapy and Day 84 ] [ Designated as safety issue: No ]
  • Mycological Response [ Time Frame: Day 28, end of combined therapy and Day 84 ] [ Designated as safety issue: No ]
  • Survival at Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: December 2002
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Micafungin
IV
Other Names:
  • Mycamine
  • FK463
Drug: Liposomal Amphotericin B
IV
Other Name: AmBisome

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047827

Locations
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Detroit, Michigan, United States, 48201
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, Tennessee
Memphis, Tennessee, United States, 38105
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma US, Inc.
  More Information

No publications provided

Responsible Party: Sr Manager Clinical Trials Registry, Astellas Pharma US, Inc
ClinicalTrials.gov Identifier: NCT00047827     History of Changes
Other Study ID Numbers: 01-0-125, FG463-21-11
Study First Received: October 18, 2002
Last Updated: September 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Aspergillus
Aspergillosis
Anti-Fungal
AmBisome
Micafungin

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Amphotericin B
Liposomal amphotericin B
Micafungin
Amebicides
Antiprotozoal Agents
 Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013