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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials13
Total Enrollment1,861

FDA Designations

No designations recorded

Clinical trial landscape

activated recombinant human factor VII · 19 trials · 18 indications

Phase 3 1Phase 2 13Phase 1 5
NCT01562574Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart DiseaseAcquired Bleeding Disorder
COMPLETED82 Analytics
PHASE3COMPLETED
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
Acquired Bleeding Disorder
NCT0156257482
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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
Reduction of bleeds
During 3 months treatment period as compared to 3 months observation period
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)
Reduction of hematuria that failed 24-hour standard therapy evaluated by change of urine color
Reduction of hematuria that failed 24-hour standard therapy evaluated by urine haemoglobin content
Reduction of hematuria that failed 24-hour standard therapy evaluated by urocrit
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
TEG® (Thromboelastography) parameters after dosing of trial product
ROTEM® (Thromboelastometry) parameters after dosing of trial product
Dose Response to Recombinant Factor VIIa
Area under the concentration curve from 0-12 hours
Area under the Curve (AUC) of FVII:C (Factor VII clotting activity) from 0-24 hours

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 -
Factor VIIEXPERIMENTAL -
High doseEXPERIMENTAL -
Low doseEXPERIMENTAL -
rFVIIaEXPERIMENTAL -
Medium doseEXPERIMENTAL -
CP-rFVIIaACTIVE_COMPARATOR -
VII25EXPERIMENTAL -
AdultsEXPERIMENTAL -
PaediatricEXPERIMENTAL -
Treatment sequence 1EXPERIMENTAL -
Treatment sequence 2EXPERIMENTAL -
Treatment sequence 3EXPERIMENTAL -
Treatment sequence 4PLACEBO_COMPARATOR -

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 to 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 KingdomUnited StatesArgentinaBrazilBulgariaPhilippinesRomaniaRussiaSouth AfricaTurkey (Türkiye)BelgiumNorwaySwedenChinaThailandMalaysiaGreece
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Frequently asked questions about activated recombinant human factor VII

What is activated recombinant human factor VII used for?

Activated recombinant human factor VII is used for other haemostasis disorders, congenital bleeding disorders, and acquired bleeding disorders. It is being developed by Novo Nordisk A/S for rare disease indications. The drug is currently in Phase 3 clinical development.

Who makes activated recombinant human factor VII?

Novo Nordisk A/S (ticker: NVO) is developing activated recombinant human factor VII. The company is conducting clinical trials for this investigational drug in indications such as acquired bleeding disorder, congenital bleeding disorder, and other haemostasis disorders.

What phase is activated recombinant human factor VII in?

Activated recombinant human factor VII is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The development program includes 13 completed trials with a total enrollment of 1,861 participants.

What clinical trials is activated recombinant human factor VII in?

Activated recombinant human factor VII has completed 13 clinical trials, including NCT00123591 in traumatic brain injury, NCT00426803 in acute intracerebral haemorrhage, NCT01561417 in congenital FVII deficiency and haemophilia, and NCT01563445 in acute intracerebral haemorrhage. All trials are completed with no active trials ongoing.

How does activated recombinant human factor VII work?

Activated recombinant human factor VII works by promoting blood clotting. It is a small molecule that targets the coagulation pathway to help control bleeding in patients with haemostasis disorders. The drug is being studied for its ability to reduce bleeding in various conditions.

Is activated recombinant human factor VII the same as NovoSeven?

Activated recombinant human factor VII is also known as NovoSeven. Clinical trial NCT01561417 specifically compares the bioequivalence of NovoSeven and a room-temperature stable formulation of NovoSeven in healthy subjects, confirming the drug's alternative name.