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

CSL Behring

Status and phase: Enrolling; Phase 3

Conditions: Acquired Fibrinogen Deficiency

Treatments: Biological: Cryoprecipitate; Biological: CSL511 Fibrinogen concentrate (human)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06617897

CSL511_3003

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

CSL511

Experimental group

Treatment:

Biological: CSL511 Fibrinogen concentrate (human)

Cryoprecipitate

Active Comparator group

Treatment:

Biological: Cryoprecipitate