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BT524

Phase 3

Bleeding Disorder | Monoclonal antibody | Other |Icon Plc|Last Updated: Jun 13, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment222
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03444324Adjusted Fibrinogen Replacement StrategyPHASE3 COMPLETED 222 — — Apr 3, 2018Nov 21, 2023Jun 13, 202519 Belgium, Czechia +5
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Study Endpoints
Primary Endpoints
Intra-operative Blood Loss
From decision to treat the subject with IMP until end of surgery, an average of 5 hours

Intra-operative blood loss as measured by amount of blood from blood suction unit and amount of blood from surgical cloths and compresses.

Secondary Endpoints
Proportion (%) of Subjects With Successful Correction of Fibrinogen Level (FIBTEM A10) 15 Minutes After Start of First IMP Administration
Prior first dose, 15 minutes after start of first IMP administration
Time to First Successful Correction of Fibrinogen Level
prior 1st dose, pre-dose, 15 minutes and 90 minutes after start of first IMP administration, end of surgery
Transfusion Requirements: Cell Salvage
After start of first IMP administration until end of surgery, an average of 5 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BT524EXPERIMENTALInvestigational Human Fibrinogen Concentrate
Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo)ACTIVE_COMPARATORStandard of Care
Interventions
NameTypeDescription
BT524BIOLOGICALBT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition.
FFP/CryoBIOLOGICALFFP/Cryo was administered intravenously; dosage according to local standards. FFP, 15 mL per kg body weight (BW); Cryoprecipitate, fixed dose of 10 units.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: At screening: 1. Written informed consent 2. Subjects scheduled for elective major spinal surgery or cytoreductive pseudomyxoma peritonei (PMP) surgery with expected major blood loss 3. Male or female, aged ≥ 18 years 4. No increased bleeding risk as assessed by standard coagul...

Countries:BelgiumCzechiaGermanyPolandSpainSwitzerlandUnited Kingdom
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