NovoSeven (eptacog alfa) / Novo Nordisk 
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 65 Diseases   5 Trials   5 Trials   369 News 


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  • ||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] Management of pregnancy‐associated acquired haemophilia A: a case‐series from the Oxford Haemophilia and Thrombosis Centre, UK () -  Jan 5, 2021 - Abstract #BSHI2020BSH-I_152;    
    She was then started on mycophenolate mofetil (MMF) (initially 500 mg twice daily, increased to 1 g twice daily)...There is very limited evidence on the management of AHA during pregnancy, with few reported cases in the literature. Careful patient counselling is essential at all times, as immunosuppressants can cross the placenta and pass into breastmilk, and so close liaison with the obstetric and pharmacy teams is vital in the management of these patients.
  • ||||||||||  NovoSeven (eptacog alfa) / Novo Nordisk
    Trial completion date, Trial primary completion date:  FASTEST: Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (clinicaltrials.gov) -  Nov 24, 2020   
    P3,  N=860, Not yet recruiting, 
    Careful patient counselling is essential at all times, as immunosuppressants can cross the placenta and pass into breastmilk, and so close liaison with the obstetric and pharmacy teams is vital in the management of these patients. Trial completion date: Aug 2025 --> Mar 2025 | Trial primary completion date: Aug 2025 --> Mar 2025
  • ||||||||||  NovoSeven (eptacog alfa) / Novo Nordisk
    Trial completion date:  FASTEST: Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial (clinicaltrials.gov) -  Nov 17, 2020   
    P3,  N=860, Not yet recruiting, 
    Trial completion date: Aug 2025 --> Mar 2025 | Trial primary completion date: Aug 2025 --> Mar 2025 Trial completion date: Aug 2026 --> Aug 2025
  • ||||||||||  Hemlibra (emicizumab-kxwh) / Roche
    [VIRTUAL] Thein Vitroprocoagulant Effects of Standard and Extended Half-Life Recombinant Factor IX Concentrates in Patients on Prophylaxis with Emicizumab () -  Nov 5, 2020 - Abstract #ASH2020ASH_4865;    
    Global coagulation assays suggest that increasing endogenous FIX levels with two rFIX concentrates that have different FIXa content and half-life, produce an enhanced procoagulant effect of Emicizumab opening the idea of the use of these concentrates as an alternative treatment for bleedings in patients with inhibitors on prophylaxis with Emicizumab. Further studies need to be performed to evaluate the procoagulant activity of the concomitant use of different rFIX concentrates and Emicizumab, and to assess security of this therapeutic approach.
  • ||||||||||  Hemlibra (emicizumab-kxwh) / Roche
    [VIRTUAL] Real-World Safety of Emicizumab: The First Interim Analysis of the European Haemophilia Safety Surveillance (EUHASS) Database (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_3483;    
    However, early data from the first Phase III trial, HAVEN 1, identified a risk for thrombotic microangiopathy (TMA) or thrombotic events (TEs) when emicizumab was used alongside activated prothrombin complex concentrate (aPCC [FEIBA]; dosed on average a cumulative amount of >100 U/kg/24 hours for ≥24 hours) leading to a warning in the label and ongoing safety monitoring...Concurrent treatments included recombinant activated factor VII (rFVIIa; NovoSeven®; n=23 PwHA), factor VIII, (FVIII products other than Obizur®; n=9 PwHA) and aPCC (n=1 PwHA)...No new or emerging safety signals for emicizumab were identified. However, this analysis was limited by the low number of emicizumab treated PwHA—especially in those without FVIII inhibitors, and relatively short exposure time to emicizumab.
  • ||||||||||  NovoSeven (eptacog alfa) / Novo Nordisk
    [VIRTUAL] Molecular Characterization of Two Homozygous Factor VII Variants Associated with Intracranial Bleeding (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_2239;    
    One of them had concomitant high titer FVII inhibitor that developed soon after initiation of treatment with recombinant FVII (eptacog alfa, NovoSeven)...The inhibitor development in P1 was likely linked to the complete absence of circulating FVII. The molecular mechanism underlying the FVII-c.718 mutation could be reduced secretion caused by protein destabilization and misfolding.
  • ||||||||||  NovoSeven (eptacog alfa) / Novo Nordisk
    Trial completion date, Trial primary completion date:  Study Comparing the Pharmacokinetic of Biosimilar Eptacog Alfa With Novoseven (clinicaltrials.gov) -  Jul 10, 2020   
    P3,  N=50, Recruiting, 
    Here reported was the detection of F5F8D in a child who presented with bleeding following trauma and prolonged PT and APTT. Trial completion date: Jul 2020 --> Oct 2020 | Trial primary completion date: May 2020 --> Sep 2020
  • ||||||||||  NovoSeven (eptacog alfa) / Novo Nordisk
    Enrollment open:  Clinical Outcomes of NovoSeven (clinicaltrials.gov) -  Jul 9, 2020   
    P=N/A,  N=225, Enrolling by invitation, 
    Trial primary completion date: Jun 2020 --> Oct 2020 Not yet recruiting --> Enrolling by invitation
  • ||||||||||  NovoSeven (eptacog alfa) / Novo Nordisk
    New trial:  Clinical Outcomes of NovoSeven (clinicaltrials.gov) -  Jun 23, 2020   
    P,  N=225, Not yet recruiting, 
  • ||||||||||  NovoSeven (eptacog alfa) / Novo Nordisk, Feiba (human plasma derived anti-inhibitor coagulant complex) / Takeda
    [VIRTUAL] The epidemiology, current treatment and care for haemophilia patients in Hong Kong () -  Jun 8, 2020 - Abstract #WFH2020WFH_545;    
    Quite a high proportion of paediatric patients can acquire satisfactory bleeding control with once weekly prophylactic replacement. Our review would facilitate future healthcare planning for haemophiliac patients.
  • ||||||||||  Enrollment open, Trial initiation date:  MOTIVATE: Treatment of Hemophilia A Patients With FVIII Inhibitors (clinicaltrials.gov) -  Jun 1, 2020   
    P=N/A,  N=120, Recruiting, 
    These results are in agreement with those reported elsewhere for a HA patient receiving emicizumab prophylaxis during ITI, who required treatment with rFVIIa. Not yet recruiting --> Recruiting | Initiation date: Jun 2020 --> Mar 2020
  • ||||||||||  Rituxan (rituximab) / Roche, Biogen, Zenyaku Kogyo
    Management of pregnancy‐associated acquired haemophilia A: a case‐series from the Oxford Haemophilia and Thrombosis Centre, UK () -  May 14, 2020 - Abstract #BSH2020BSH_114;    
    She was then started on mycophenolate mofetil (MMF) (initially 500 mg twice daily, increased to 1 g twice daily)...There is very limited evidence on the management of AHA during pregnancy, with few reported cases in the literature. Careful patient counselling is essential at all times, as immunosuppressants can cross the placenta and pass into breastmilk, and so close liaison with the obstetric and pharmacy teams is vital in the management of these patients.
  • ||||||||||  NovoSeven (eptacog alfa) / Novo Nordisk
    [VIRTUAL] Efficacy of Novoseven in the Treatment of Bleeding Episodes During Glanzmann´s Thrombasthenia (Virtual Meeting Room 6) -  May 14, 2020 - Abstract #ISTH2020ISTH_1425;    
    Careful patient counselling is essential at all times, as immunosuppressants can cross the placenta and pass into breastmilk, and so close liaison with the obstetric and pharmacy teams is vital in the management of these patients. During TG, the efficacy of recombinant factor VII was established in patients with anti-GP IIbIIIa or anti-HLA alloimmunization or an absence of response to platelet transfusions or in the context of emergency in the absence of platelet concentrates.
  • ||||||||||  Hemlibra (emicizumab-kxwh) / Roche
    [VIRTUAL] Major Surgery in Emicizumab Haven 1 Trial Patients: The New Zealand Experience (Virtual Meeting Room 6) -  May 14, 2020 - Abstract #ISTH2020ISTH_864;    
    Major surgery can be safely performed in patients on Emicizumab receiving high dose FVIII replacement where the inhibitor can be swamped or using high doses of Novoseven. Neither patient developed microangiopathic haemolysis nor other thrombotic complication despite TxAc and intensive transfusion support.
  • ||||||||||  Sevenfact (eptacog beta activated) / LFB Biotechnologies, HEMA Biologics
    Journal:  Eptacog beta: a novel recombinant human factor VIIa for the treatment of hemophilia A and B with inhibitors. (Pubmed Central) -  May 7, 2020   
    The available data indicate that activated eptacog beta exhibits structural (N- and O- glycosylation), pharmacodynamic and pharmacokinetic characteristics similar to activated eptacog alfa, its main competitor, but binds slightly better to platelets and HUVEC, and it is safe and effective. Expert commentary: This critical review of available data on activated eptacog beta shows that it represents an alternative source of rhFVIIa at potentially lower cost with easily expandable manufacturing capacity that could contribute to cover the future patient needs.
  • ||||||||||  Alhemo (concizumab) / Novo Nordisk
    Trial completion:  explorer (clinicaltrials.gov) -  Feb 10, 2020   
    P2,  N=26, Completed, 
    This approach may reduce burden on nursing staff, potentially minimize the risk of human error and avoid delay in administration of rFVIIa. Active, not recruiting --> Completed
  • ||||||||||  NovoSeven (eptacog alfa) / Novo Nordisk
    Factor VII deficiencies and surgeries () -  Feb 4, 2020 - Abstract #EAHAD2020EAHAD_515;    
    According to our single center experience, rFVIIa is necessary to prevent bleeding risk during surgeries when FVII:C is <5 IU/dL. For patients with 5≤FVII:C <30 IU/dL, rFVIIa did not seem to be necessary to prevent surgical hemmorhagic risk.
  • ||||||||||  Idelvion (albutrepenonacog alfa) / CSL Behring, BeneFix (nonacog alfa) / Pfizer, NovoSeven (eptacog alfa) / Novo Nordisk
    Case report: A pediatric patient with severe hemophilia B, inhibitor development and successful ITI () -  Feb 4, 2020 - Abstract #EAHAD2020EAHAD_395;    
    After 2 months of prophylactic treatment with Nonacog alfa (8 exposure days), it was decided to change to prophylactic treatment with Albutrepenonacog alfa...A permanent central venous device (PAC) was inserted while the child was treated with Eptacog alfa for 10 days... Four months after ITI start, the treatment is succesfull and without side effects.
  • ||||||||||  Hemlibra (emicizumab-kxwh) / Roche, NovoSeven (eptacog alfa) / Novo Nordisk, Feiba (human plasma derived anti-inhibitor coagulant complex) / Takeda
    Evaluation of a blood coagulation factor IX variant that functions independently of factor VIII as an alternative treatment of hemophilia A () -  Feb 4, 2020 - Abstract #EAHAD2020EAHAD_295;    
    Adding 100% FVIII or emicizumab to FVIII‐deficient plasma with FIX‐FIAV resulted in synergistic enhancement of thrombin generation, with a 9‐fold increase in thrombin peak, consistent with previously shown hyperactivity of FIX‐FIAV in a cofactor‐dependent system. FIX‐FIAV has a mechanism of activation capable of sustaining therapeutic levels of coagulation activity in FVIII deficiency, supporting its potential as a treatment for HA.
  • ||||||||||  Hemlibra (emicizumab-kxwh) / Roche
    Fix concentrates might increase procoagulant effect of emicizumab () -  Feb 4, 2020 - Abstract #EAHAD2020EAHAD_275;    
    Three global haemostasis assays indicate that low increments of FIX plasma activity produce an enhanced procoagulant effect of emicizumab in patients with inhibitors opening the idea of the use of FIX concentrates as an alternative treatment of bleedings in this type of patients. However, preclinical studies are necessary to test the in vivo clinical efficacy and thrombotic risk of the concomitant use of FIX and emicizumab.
  • ||||||||||  NovoSeven (eptacog alfa) / Novo Nordisk
    Trial completion date, Trial primary completion date:  Study Comparing the Pharmacokinetic of Biosimilar Eptacog Alfa With Novoseven (clinicaltrials.gov) -  Jan 7, 2020   
    P3,  N=50, Recruiting, 
    However, preclinical studies are necessary to test the in vivo clinical efficacy and thrombotic risk of the concomitant use of FIX and emicizumab. Trial completion date: Dec 2019 --> Jul 2020 | Trial primary completion date: Jun 2019 --> May 2020
  • ||||||||||  NovoSeven (eptacog alfa) / Novo Nordisk
    An Update on rFVIIa Use in Females with Rare Bleeding Disorders (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_1927;    
    Recombinant FVIIa (rFVIIa; NovoSevenRT®) is available for the management of these two RBDs...Conclusion Without therapy, patients with RBDs may have high rates of bleeding with considerable risk of morbidity and mortality . Data presented here indicate that rFVIIa-based treatment regimens have an acceptable safety profile and are effective in the management of bleeds and surgeries in women with GT or FVII-CD.