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Study of FK463 for the Treatment of Invasive Aspergillosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036166
Recruitment Status : Completed
First Posted : May 9, 2002
Last Update Posted : January 10, 2018
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with proven or probable invasive infections due to Aspergillus species.

Condition or disease Intervention/treatment Phase
Aspergillosis Drug: FK463 Phase 2

Detailed Description:
This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis
Actual Study Start Date : January 29, 1999
Actual Primary Completion Date : January 31, 2002
Actual Study Completion Date : January 31, 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Has proven or probable systemic infection with Aspergillus species

Exclusion Criteria

  • Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
  • Has bronchopulmonary aspergillosis, aspergillomas, sinus aspergillosis or external otitis but does not have histologic evidence of tissue invasion
  • Has life-expectancy judged to be less than 5 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 identifier (NCT number): NCT00036166

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Sponsors and Collaborators
Astellas Pharma Inc

Additional Information:
Publications of Results:
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Responsible Party: Astellas Pharma Inc Identifier: NCT00036166    
Other Study ID Numbers: FG463-21-01
98-0-046 ( Other Identifier: Alternate Protocol Number )
First Posted: May 9, 2002    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: June 2015
Keywords provided by Astellas Pharma Inc:
Additional relevant MeSH terms:
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Antifungal Agents
Anti-Infective Agents