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

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

NCT ID: NCT06617897

Condition: Acquired Fibrinogen Deficiency

Conditions: Official terms:
Pseudomyxoma Peritonei
Afibrinogenemia

Conditions: Keywords:
Fibrinogen deficiency
Pseudomyxoma peritonei
Cytoreductive surgery
Hyperthermic intraperitoneal chemotherapy
Blood coagulation disorder

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: CSL511 Fibrinogen concentrate (human)
Description: CSL511 will be prepared in sterile water for injection and administered as an intravenous (IV) infusion.
Arm group label: CSL511

Intervention type: Biological
Intervention name: Cryoprecipitate
Description: Cryoprecipitate will be administered via IV infusion.
Arm group label: Cryoprecipitate

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.

Criteria for eligibility:
Criteria:
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 (eg, von Willebrand's disease, hemophilia, or severe liver disease) or a prothrombotic disorder (eg, protein C or S deficiency, or heparin induced thrombocytopenia). - Myocardial infarction, acute coronary syndrome, or stroke within 2 months before study surgery. - Positive viral serology for hepatitis A virus, hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus (HIV)-1/2, or parvovirus B19 at the Screening Visit. - 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: September 30, 2024

Completion date: October 30, 2026

Lead sponsor:
Agency: CSL Behring
Agency class: Industry

Source: CSL Behring

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06617897