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New treatment option for Acquired Fibrinogen Deficiency
Official title Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
ClinicalTrials.gov ID: NCT06617897
What this study is testing
What is CSL511 Fibrinogen concentrate (human)?
CSL511 Fibrinogen concentrate (human) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acquired fibrinogen deficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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.
See the full eligibility 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basingstoke, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basingstoke, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.