Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 4:14 AM
Study NCT ID:
NCT05897294
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2024-11-21
First Post:
2023-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Voriconazole Inhalation Powder for the Treatment of Pulmonary Aspergillosis
Sponsor:
TFF Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
Use of Voriconazole Inhalation Powder for the Treatment of Pulmonary Aspergillosis
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2024-11
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:
Voriconazole Inhalation Powder is available on an expanded access basis to patients with pulmonary aspergillosis for up to 12 weeks. Duration of treatment may be extended on a case-by-case basis depending on drug availability and after discussion with the Sponsor.
Detailed Description:
The purpose of this expanded access protocol is to provide, upon the treating clinician's request and Sponsor assessment, Voriconazole Inhalation Powder to patients with pulmonary aspergillosis, or patients with other voriconazole-sensitive pulmonary fungal infections, who have limited or no other treatment options or who have had unfavorable response to adequate standard of care antifungal therapy including to oral or intravenous voriconazole.
Reporting of serious adverse events (SAE) and Adverse Events of Special Interest (AESI) are required under this expanded access protocol. Patient treatment and outcomes information are also intended to be gathered under this protocol to the extent feasible (e.g., disease progression/improvement after treatment).
Reporting of serious adverse events (SAE) and Adverse Events of Special Interest (AESI) are required under this expanded access protocol. Patient treatment and outcomes information are also intended to be gathered under this protocol to the extent feasible (e.g., disease progression/improvement after treatment).
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?: