Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-28 @ 4:06 PM
Study NCT ID:
NCT00036166
Status:
COMPLETED
Last Update Posted:
2018-01-10
First Post:
2002-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of FK463 for the Treatment of Invasive Aspergillosis
Sponsor:
Astellas Pharma Inc
Organization:
Study Overview
Official Title:
An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 98-0-046 | OTHER | Alternate Protocol Number | View |