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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acquired Fibrinogen Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CSL511

Group Type EXPERIMENTAL

CSL511 Fibrinogen concentrate (human)

Intervention Type BIOLOGICAL

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

Cryoprecipitate

Group Type ACTIVE_COMPARATOR

Cryoprecipitate

Intervention Type BIOLOGICAL

Cryoprecipitate will be administered via IV infusion.

Interventions

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CSL511 Fibrinogen concentrate (human)

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

Intervention Type BIOLOGICAL

Cryoprecipitate

Cryoprecipitate will be administered via IV infusion.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No