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An Open-Label, Non-Comparative Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis


Phase 2
18 Years
N/A
Not Enrolling
Both
Candidiasis

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Trial Information

An Open-Label, Non-Comparative Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis


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

Inclusion Criteria


Inclusion Criteria

- Has Candidemia or invasive candidiasis documented by typical clinical signs and
symptoms and confirmed by fungal culture or histologic confirmation

Exclusion Criteria

- Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal

- Has life expectancy judged to be less than 5 days

- De novo patients who have received a systemic antifungal agent for the treatment of
this episode of candidemia or invasive candidiasis for more than 48 hours prior to
the first dose of FK463; or efficacy failure patients who have received =< 5 days of
prior systemic antifungal therapy for the treatment of this episode of candidemia or
invasive candidiasis

- Require treatment with topical or systemic antifungal agents for conditions other
than candidemia or invasive candidiasis

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

FG463-21-02

NCT ID:

NCT00036179

Start Date:

February 1999

Completion Date:

December 2002

Related Keywords:

  • Candidiasis
  • Candidemia
  • Anti-Fungal
  • Candidiasis
  • Candidemia
  • Candidiasis, Invasive

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