Study of FK463 for the Treatment of Invasive Aspergillosis

An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00036166

Enrollment

326

Registered

2002-05-09

Start date

1999-01-29

Completion date

2002-01-31

Last updated

2018-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspergillosis

Keywords

Aspergillus, Anti-Fungal

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.

Detailed description

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

Interventions

DRUGFK463

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

Austria, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026