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

NCT06617897 | Recruiting Phase 3 DMC

• 1 other identifier: CSL511_3003
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acquired Fibrinogen Deficiency

Keywords

Fibrinogen deficiency; Pseudomyxoma peritonei; Cytoreductive surgery; Hyperthermic intraperitoneal chemotherapy; Blood coagulation disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Number of participants with treatment-emergent (TE): adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs)

  Up to 30 days after IV infusion

• Number of participants with intraoperative hemostatic efficacy

  During surgery

• Number of participants with postoperative hemostatic efficacy

  Up to 24 hours after surgery

• 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

Study Arms (2)

CSL511

EXPERIMENTAL

Biological: CSL511 Fibrinogen concentrate (human)

Cryoprecipitate

ACTIVE COMPARATOR

Biological: Cryoprecipitate

Interventions

CSL511 Fibrinogen concentrate (human) BIOLOGICAL

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

CSL511

Cryoprecipitate BIOLOGICAL

Cryoprecipitate will be administered via IV infusion.

Cryoprecipitate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (1)

Basingstoke and North Hampshire Hospital

Basingstoke, RG24 9NA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Afibrinogenemia; Pseudomyxoma Peritonei; Blood Coagulation Disorders

Interventions

cryoprecipitate coagulum

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Adenocarcinoma, Mucinous; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous

Study Officials

• Study Director

  CSL Behring

  STUDY DIRECTOR

Central Study Contacts

Trial Registration Coordinator

CONTACT

+1 610-878-4697; clinicaltrials@cslbehring.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 29, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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
• 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.

Locations

GB (1)