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

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.

Study Overview

• Status: Recruiting
• Conditions: Acquired Fibrinogen Deficiency
• Intervention / Treatment: Biological: CSL511 Fibrinogen concentrate (human); Biological: Cryoprecipitate

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Trial Registration Coordinator; Phone Number: +1 610-878-4697; Email: clinicaltrials@cslbehring.com

Study Locations

• United Kingdom
  • Basingstoke, United Kingdom, RG24 9NA
    • Recruiting
    • Basingstoke And North Hampshire Hospital
    • Contact: Asoke Roy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Aged >= 18 years at the time of providing written informed consent.
• • Diagnosis of PMP requiring CRS with HIPEC.
• • Bleeding risk: Predicted intraoperative blood loss of >=2L, assessed within 60 and 100 mins after start of study surgery (assessment made before 2 L of blood is lost)

Exclusion Criteria:

• • Confirmed or suspected congenital or acquired coagulation disorder or a prothrombotic disorder
• • Myocardial infarction, acute coronary syndrome, or stroke within 2 months before study surgery.
• • Known history of chronic hepatitis.
• • Clopidogrel or ticagrelor administration within 5 days before study surgery.
• • Prasugrel administration within 7 days before study surgery.
• • Oral factor Xa inhibitor administration within 2 days before study surgery.
• • Glycoprotein IIb / IIIa antagonist administration within 24 hours before study surgery.
• • Oral direct thrombin inhibitor administration within 3 days before study surgery.
• • Vitamin K antagonists within 5 days before study surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cryoprecipitate	Biological: Cryoprecipitate; Cryoprecipitate will be administered via IV infusion.
Experimental: CSL511	Biological: CSL511 Fibrinogen concentrate (human); CSL511 will be prepared in sterile water for injection and administered as an intravenous (IV) infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with overall hemostatic success	Overall hemostatic success will be assessed by an independent data monitoring and efficacy adjudication committee (IDMEAC). The IDMEAC will assess the overall efficacy based on a composite of intraoperative and postoperative hemostasis using a 4-point scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure).	During surgery to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss		During surgery
Number of participants with treatment-emergent (TE): adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs)	The TE AESIs include thromboembolic events, viral transmission/seroconversion, and anaphylaxis and severe hypersensitivity/severe allergic reactions.	Up to 30 days after IV infusion
Plasma fibrinogen concentration		During surgery, at the end of surgery and up to 24 hours after start of surgery
Mean total dose of fibrinogen administered		During surgery, at the end of surgery and up to 24 hours after start of surgery
Intraoperative requirements for blood products	Blood products include fresh frozen plasma, red blood cells, and platelets.	During surgery
Postoperative blood loss		Up to 48 hours after start of surgery
Postoperative requirements for blood products	Blood products include fresh frozen plasma, red blood cells, and platelets.	Up to 9 days after surgery
Number of participants with reoperation (for bleeding)		Up to 30 days after surgery
Number of participants with reoperation (for reasons other than bleeding)		Up to 30 days after surgery
Duration of mechanical ventilation		Up to 30 days after surgery
Duration of intensive care unit (ICU) stay		Up to 30 days after surgery
Duration of hospital stay		Up to 30 days after surgery
21-day mortality		Up to 21 days after surgery
In-hospital mortality		Up to 30 days after surgery
Time between placing the investigational product (IP) order to administration	The following time to event parameters will be assessed: time between when IP is ordered and when IP is ready to administer in the operating room and time between when IP is ordered and start of IP administration.	During surgery
Prothrombin time and activated partial thromboplastin time		Up to 8 days after surgery
Coagulation parameter profile	The following coagulation parameter profiles will be assessed: thrombin generation marker, protein C and S, antithrombin and alpha 2-antiplasmin.	Up to 8 days after surgery
Coagulation factor profile	The following coagulation factor profiles will be assessed: fibrinogen, factor VIII (FVIII):C, von Willebrand ristocetin cofactor (VWF:Rco) and factor XIII (FXIII).	Up to 8 days after surgery
Number of participants with intraoperative hemostatic efficacy	Intraoperative hemostatic efficacy will be assessed by the surgeon and anesthesiologist using an objective 4-point hemostatic efficacy scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure).	During surgery
Number of participants with postoperative hemostatic efficacy	Postoperative hemostatic efficacy will be assessed by a hematologist using an objective 4-point hemostatic efficacy scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure).	Up to 24 hours after surgery
Number of doses of fibrinogen administered		During surgery, at the end of surgery and up to 72 hours after start of surgery
Duration of surgery		During surgery

Collaborators and Investigators

• Sponsor: CSL Behring
• Investigators: Study Director: Study Director, CSL Behring

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 29, 2027

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Hyperthermic intraperitoneal chemotherapy; Pseudomyxoma peritonei; Cytoreductive surgery; Blood coagulation disorder; Fibrinogen deficiency
• Additional Relevant MeSH Terms: Neoplasms; Genetic Diseases, Inborn; Neoplasms by Histologic Type; Hematologic Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Hemorrhagic Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Neoplasms, Cystic, Mucinous, and Serous; Adenocarcinoma, Mucinous; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Pseudomyxoma Peritonei; Blood Coagulation Disorders; Afibrinogenemia; cryoprecipitate coagulum
• Other Study ID Numbers: CSL511_3003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
• IPD Sharing Time Frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available

IPD Sharing Access Criteria

Proposed research should seek to answer a previously unanswered important medical or scientific question.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No