Study of FK463 for the Treatment of Invasive Aspergillosis

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00036166
First received: May 8, 2002
Last updated: April 4, 2011
Last verified: April 2011

May 8, 2002
April 4, 2011
January 1999
December 2002   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00036166 on ClinicalTrials.gov Archive Site
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Study of FK463 for the Treatment of Invasive Aspergillosis
An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis

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.

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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aspergillosis
Drug: FK463
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
326
December 2002
December 2002   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   Italy,   Poland,   Spain,   Sweden,   United Kingdom
 
NCT00036166
FG463-21-01, 98-0-046
Not Provided
Disclosure Office Europe, Astellas Pharma Europe BV
Astellas Pharma Inc
Not Provided
Not Provided
Astellas Pharma Inc
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP