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activated recombinant human factor VII

Phase 3

Acquired Bleeding Disorder | Small molecule | Rare Disease |Novo Nordisk A/S|Last Updated: Jan 19, 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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials13
Total Enrollment1,861
FDA Designations
No designations recorded
Clinical Trials (13)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01562574Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart DiseasePHASE3 COMPLETED 82 — — Jan 1, 2002Aug 1, 2004Jan 12, 20171 Australia
NCT00123591Safety and Preliminary Efficacy of Recombinant Activated Factor VII in Subjects With Traumatic Brain InjuryPHASE2 COMPLETED 96 — — Jan 1, 2005May 1, 2006Jan 12, 201715 Canada, Finland +9
NCT00154492Use of NovoSeven® in Active Variceal BleedingPHASE2 COMPLETED 265 — — Apr 1, 2004Aug 1, 2006Jan 13, 201744 Austria, Czechia +10
NCT01601457Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture ReconstructionPHASE2 COMPLETED 48 — — Sep 1, 2002Apr 1, 2004Jan 13, 20171 United Kingdom
NCT00426803Recombinant Factor VIIa in Acute Intracerebral HaemorrhagePHASE2 COMPLETED 400 — — Aug 1, 2002Jun 1, 2004Jan 18, 201715 Australia, Austria +13
NCT01563523Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma PatientsPHASE2 COMPLETED 283 — — Mar 1, 2002Oct 1, 2003Jan 13, 20179 Australia, Austria +7
NCT01563445Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral HaemorrhagePHASE2 COMPLETED 40 — — Nov 1, 2001Mar 1, 2003Jan 13, 20171 United States
NCT01563458Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver TransplantationPHASE2 COMPLETED 208 — — Aug 1, 2001Aug 1, 2003Jan 13, 201718 Australia, Canada +5
NCT01566786Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral HaemorrhagePHASE2 COMPLETED 48 — — Aug 1, 2001Oct 1, 2002Jan 12, 20179 Australia, Denmark +7
NCT01562821Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial HepatectomyPHASE2 COMPLETED 235 — — Jul 1, 2001Dec 1, 2002Jan 13, 20177 China, Taiwan +1
NCT01601613Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic FeverPHASE2 COMPLETED 28 — — Jul 1, 2001Nov 1, 2002Jan 11, 20179 Malaysia, Philippines +1
NCT01562158Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell TransplantationPHASE2 COMPLETED 100 — — Apr 1, 2001Oct 1, 2003Jan 11, 201746 United States, Australia +14
NCT01561417Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male SubjectsPHASE1 COMPLETED 28 — — Apr 1, 2006Sep 1, 2006Jan 19, 20171 France
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Study Endpoints
Primary Endpoints
Time from reversal of heparin with protamine sulphate to chest closure
Evaluate the Safety of Recombinant Activated Factor VII in Subjects with Brain Contusions
Within the first 15 days of injury
Treatment failure
Within 5 days after first trial product administration
Total volume of perioperative blood loss
Reducing haematoma growth
Number of PRBC (packed red blood cells) units (allogeneic/autologous) transfused
Occurrence of a treatment-related serious adverse event (SAE)
Total number of RBC units transfused during the perioperative period
Change in ICH volume as measured by CT head scans
The RBC transfusion requirements
Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration
Effect on bleeding, defined as change in bleeding score
Area under the plasma concentration versus time curve for FVIIa clot activity
Secondary Endpoints
Number of units/volume of fresh frozen plasma (FFP) and/or platelets and/or red-cell concentrates transfused during surgery and in the post-surgery period
Blood loss
Adverse events
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Activated recombinant human factor VIIEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
High doseEXPERIMENTAL -
Low doseEXPERIMENTAL -
rFVIIaEXPERIMENTAL -
Medium doseEXPERIMENTAL -
CP-rFVIIaACTIVE_COMPARATOR -
VII25EXPERIMENTAL -
Interventions
NameTypeDescription
activated recombinant human factor VIIDRUGUp to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered
placeboDRUGUp to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered
standard therapyPROCEDUREStandard treatment of bleeding
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Eligibility Criteria
Age RangeN/A — 1 Year
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Signed informed consent obtained from parent or legal guardian before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject * Children with complex congenital heart disease requiring ...

Countries:AustraliaCanadaFinlandGermanyIndiaIsraelItalyNetherlandsSingaporeSpainSwitzerlandTaiwanAustriaCzechiaDenmarkFranceHong KongPolandUnited KingdomBelgiumNorwaySwedenSouth AfricaUnited StatesChinaThailandMalaysiaPhilippines
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