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

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ClinicalTrials.gov Identifier: NCT00047827
Recruitment Status : Terminated (Inadequate enrollment)
First Posted : October 24, 2002
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Aspergillosis Drug: Micafungin Drug: Liposomal Amphotericin B Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2002
Actual Primary Completion Date : February 2003
Actual Study Completion Date : February 2003


Arm Intervention/treatment
Experimental: 1 Drug: Micafungin
IV
Other Names:
  • Mycamine
  • FK463

Drug: Liposomal Amphotericin B
IV
Other Name: AmBisome




Primary Outcome Measures :
  1. Incidence of treatment response defined as complete or partial response [ Time Frame: Day 28, end of combined therapy and Day 84 ]

Secondary Outcome Measures :
  1. Clinical Response [ Time Frame: Day 28, end of combined therapy and Day 84 ]
  2. Radiological Response [ Time Frame: Day 28, end of combined therapy and Day 84 ]
  3. Mycological Response [ Time Frame: Day 28, end of combined therapy and Day 84 ]
  4. Survival at Day 84 [ Time Frame: Day 84 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00047827     History of Changes
Other Study ID Numbers: 01-0-125
FG463-21-11
First Posted: October 24, 2002    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

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

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Amphotericin B
Liposomal amphotericin B
Micafungin
Echinocandins
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents