NCT06617897

Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery

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: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acquired Fibrinogen Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	CSL511 Fibrinogen concentrate (human)	CSL511 will be prepared in sterile water for injection and administered as an intravenous (IV) infusion.
BIOLOGICAL	Cryoprecipitate	Cryoprecipitate will be administered via IV infusion.

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-09-01
• Completion: 2027-10-29
• First posted: 2024-10-01
• Last updated: 2026-03-11

Locations

1 site across 1 country: United Kingdom