Study of FK463 for the Treatment of Invasive Aspergillosis

Astellas Pharma Inc326 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

326

Conditions

Aspergillosis

Interventions

FK463DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (23)

Medizinische Univ.-Klinik

Graz, Austria

Data from ClinicalTrials.gov

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