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Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Sponsor: CSL Behring
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-10-01
Completion Date
2027-10-29
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
CSL511 Fibrinogen concentrate (human)
CSL511 will be prepared in sterile water for injection and administered as an intravenous (IV) infusion.
Cryoprecipitate
Cryoprecipitate will be administered via IV infusion.
Locations (1)
Basingstoke and North Hampshire Hospital
Basingstoke, United Kingdom