Acquired Fibrinogen DeficiencyPhase 3NCT06617897
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
A Phase 3 study testing CSL511 Fibrinogen concentrate (human) and Cryoprecipitate in people with Acquired Fibrinogen Deficiency, run by CSL Behring at 1 site in United Kingdom.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Fibrinogen Deficiency
- What is being tested?
- CSL511 Fibrinogen concentrate (human) and Cryoprecipitate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2024to 30 Jun 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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)
Who cannot join
- • 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.
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- • 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Basingstoke and North Hampshire Hospital
Basingstoke, RG24 9NA
Asoke Roy
About this study
Official title: A Phase 3, Single-center, Randomized, Controlled Clinical Study to Investigate the Efficacy of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
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
- Being tested
- CSL511 Fibrinogen concentrate (human), Cryoprecipitate
- Keywords
- Fibrinogen deficiency, Pseudomyxoma peritonei, Cytoreductive surgery, Hyperthermic intraperitoneal chemotherapy, Blood coagulation disorder
- Medical subject headings
- Afibrinogenemia, Pseudomyxoma Peritonei, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL511 Fibrinogen concentrate (human)Biological
CSL511 will be prepared in sterile water for injection and administered as an intravenous (IV) infusion.
CryoprecipitateBiological
Cryoprecipitate will be administered via IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| CSL511 | Experimental | Not described Receives: Biological: CSL511 Fibrinogen concentrate (human) |
| Cryoprecipitate | Active comparator | Not described Receives: Biological: Cryoprecipitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
The TE AESIs include thromboembolic events, viral transmission/seroconversion, and anaphylaxis and severe hypersensitivity/severe allergic reactions.
Measured: Up to 30 days after IV infusion
Number of participants with intraoperative hemostatic efficacy
Intraoperative hemostatic efficacy will be assessed by the surgeon and anesthesiologist using an objective 4-point hemostatic efficacy scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure).
Measured: During surgery
Number of participants with postoperative hemostatic efficacy
Postoperative hemostatic efficacy will be assessed by a hematologist using an objective 4-point hemostatic efficacy scale, where ratings correspond to excellent or good (hemostatic success) or moderate or none (hemostatic failure).
Measured: Up to 24 hours after surgery
Plasma fibrinogen concentration
Measured: During surgery, at the end of surgery and up to 24 hours after start of surgery
Mean total dose of fibrinogen administered
Measured: During surgery, at the end of surgery and up to 24 hours after start of surgery
Number of doses of fibrinogen administered
Measured: During surgery, at the end of surgery and up to 72 hours after start of surgery
Duration of surgery
Measured: During surgery
Intraoperative blood loss
Measured: During surgery
Intraoperative requirements for blood products
Blood products include fresh frozen plasma, red blood cells, and platelets.
Measured: During surgery
Postoperative blood loss
Measured: Up to 48 hours after start of surgery
Postoperative requirements for blood products
Blood products include fresh frozen plasma, red blood cells, and platelets.
Measured: Up to 9 days after surgery
Number of participants with reoperation (for bleeding)
Measured: Up to 30 days after surgery
Number of participants with reoperation (for reasons other than bleeding)
Measured: Up to 30 days after surgery
Duration of mechanical ventilation
Measured: Up to 30 days after surgery
Duration of intensive care unit (ICU) stay
Measured: Up to 30 days after surgery
Duration of hospital stay
Measured: Up to 30 days after surgery
21-day mortality
Measured: Up to 21 days after surgery
In-hospital mortality
Measured: Up to 30 days after surgery
Time between placing the investigational product (IP) order to administration
The following time to event parameters will be assessed: time between when IP is ordered and when IP is ready to administer in the operating room and time between when IP is ordered and start of IP administration.
Measured: During surgery
Prothrombin time and activated partial thromboplastin time
Measured: Up to 8 days after surgery
Coagulation parameter profile
The following coagulation parameter profiles will be assessed: thrombin generation marker, protein C and S, antithrombin and alpha 2-antiplasmin.
Measured: Up to 8 days after surgery
Coagulation factor profile
The following coagulation factor profiles will be assessed: fibrinogen, factor VIII (FVIII):C, von Willebrand ristocetin cofactor (VWF:Rco) and factor XIII (FXIII).
Measured: Up to 8 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Oct 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Fibrinogen DeficiencyStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617897
- Sponsor's protocol ID
- CSL511_3003
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.