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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 (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00047827
First received: October 18, 2002
Last updated: August 19, 2014
Last verified: August 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Astellas Pharma 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: August 19, 2014
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
Dermatomycoses
Hyalohyphomycosis
Infection
Mycoses
Skin Diseases
Skin Diseases, Infectious
Amphotericin B
Liposomal amphotericin B
Micafungin
Amebicides
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014