clinical trial · NCT06617897
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
CSL Behring·phase3·recruiting·n = 90
Acquired Fibrinogen DeficiencyCSL511 Fibrinogen concentrate (human)Cryoprecipitate
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 1:1 ratio to 1 of 2 treatment arms, to receive CSL511 or cryoprecipitate.
started
Oct 1, 2024
primary completion
Sep 1, 2027
completion
Oct 29, 2027
last updated
Mar 11, 2026
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol