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eptacog alfa

Phase 3

Acquired Bleeding Disorder | Small molecule | Other |Novo Nordisk A/S|Last Updated: Jan 13, 2017

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
RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment969
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00127283Recombinant Factor VIIa in Acute Intracerebral HaemorrhagePHASE3 COMPLETED 829 — — May 1, 2005Jan 1, 2007Jan 12, 2017167 United States, Australia +21
NCT00266006Factor VIIa in Acute Intracerebral HaemorrhagePHASE2 COMPLETED 90 — — Jan 1, 2006Apr 1, 2007Nov 18, 20161 Japan
NCT00102037Use of Activated Recombinant FVII in Spinal SurgeryPHASE2 COMPLETED 50 — — Jul 1, 2004Feb 1, 2006Jan 13, 201714 United States
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Study Endpoints
Primary Endpoints
Reducing disability and improving clinical outcome
After 3 months
The Occurrence of thromboembolic serious adverse event
Until 90 days
Safety variables
Within 30 days after surgery
Secondary Endpoints
Reducing mortality
Reducing hematoma growth
Reducing disability and improving clinical outcome
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
eptacog alfa (activated)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites167

Inclusion Criteria: * Spontaneous intracranial hemorrhage (ICH) within 3 hours after first symptom Exclusion Criteria: * Patients with secondary ICH * Pre-existing disability * Haemophilia

Countries:United StatesAustraliaAustriaBelgiumBrazilCanadaChinaCroatiaDenmarkFinlandFranceGermanyHong KongIsraelItalyNetherlandsNorwaySingaporeSpainSwedenSwitzerlandTaiwanThailandJapan
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