Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538480
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Confirmatory Study of PRGN-2012 in Patients with RRP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Trial of PRGN-2012 for the Treatment of Recurrent Respiratory Papillomatosis in Adult Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this confirmatory study is to provide further demonstration of the efficacy of PRGN-2012 for the treatment of RRP in adults
Detailed Description:
This is a single-arm open-label confirmatory study of PRGN-2012 in RRP patients with a history of repeated surgical debulking for the management of their disease Patients will be treated with PRGN-2012 and followed for at least 12 months to evaluate for efficacy and safety endpoints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None