Clinical Trial

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

Recruiting Phase 3
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-09-27; most recent amendment 2026-03-09.
Status change: Not Yet Recruiting → Recruiting 2024-12-09
Trial Details
NCT Number NCT06617897
Lead Sponsor CSL Behring
Conditions Acquired Fibrinogen Deficiency
Enrollment 90 participants
Start Date 2024-10-01
Primary Completion 2027-09-01 (estimated)
Study Completion 2027-10-29 (estimated)
Updated on ClinicalTrials.gov 2026-03-11