Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617897
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Phase 3 Study of Fibrinogen Concentrate CSL511 in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Single-center Randomized Controlled Clinical Study to Investigate the Efficacy of Fibrinogen Concentrate CSL511 in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This study is a phase 3 prospective single center randomized open label controlled parallel arm interventional study to investigate the efficacy and safety of CSL511 in participants undergoing cytoreductive surgery CRS with hyperthermic intraperitoneal chemotherapy HIPEC for pseudomyxoma peritonei PMP with predicted intraoperative blood loss of greater than or equal to 2 liter L Eligible participants will be randomized in a 11 ratio to 1 of 2 treatment arms to receive CSL511 or cryoprecipitate
Detailed Description:
None
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