Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

Astellas

Status and phase

Completed

Phase 2

Conditions

Candidiasis

Treatments

Drug: FK463

Study type

Interventional

Funder types

Industry

Identifiers

NCT00036179

FG463-21-02

98-0-047

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.

Full description

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

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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