RecruitingPhase 3NCT06617897

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


Sponsor

CSL Behring

Enrollment

90 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CSL511 Fibrinogen concentrate (human) and a biological treatment called Cryoprecipitate for people with acquired fibrinogen deficiency. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCSL511 Fibrinogen concentrate (human)

CSL511 will be prepared in sterile water for injection and administered as an intravenous (IV) infusion.

BIOLOGICALCryoprecipitate

Cryoprecipitate will be administered via IV infusion.


Locations(1)

Basingstoke and North Hampshire Hospital

Basingstoke, United Kingdom

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NCT06617897