Kovaltry (octocog alfa) / Bayer 
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 11 Diseases   2 Trials   2 Trials   203 News 


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  • ||||||||||  Kovaltry (octocog alfa) / Bayer, CSL Behring
    [VIRTUAL] Pharmacokinetic-guided Prophylaxis Improved Clinical Outcomes in 46 Pediatric Patients with Severe Hemophilia A (Room 3) -  Jun 9, 2021 - Abstract #ISTH2021ISTH_928;    
    After a single-dose infusion(50IU/kg) of Kovaltry, the PK tests were performed using a five-point assay, and PK parameters were calculated by WinNonlin software...In the other 5 patients with trough level reduced, lower infusion frequency[2.33(3.0,3.5) vs. 3.0(2.17, 2.67),P <0.05] and weekly FVIII consumption[58.25 vs. 75 IU/kg/week,P <0.05] were observed. In these patients, no statistical difference was found in ABR[0(0,2) vs. 1(0,2),P =0.62],AJBR [0(0,3) vs. 0(0,4),P =0.63]and ASBR[0(0,2) vs. 0(0,1),P =0.39].Table-1 Table-2 Conclusions : PK-guided prophylaxis could help hemophiliac patients improve quality of life by reducing bleeds with affordable FVIII concentrate consumption as well as decreasing infusion frequency with similar bleeds.
  • ||||||||||  Kovaltry (octocog alfa) / Bayer, CSL Behring
    Trial completion date, Trial primary completion date:  Drug Use Investigation of Kovaltry in Hemophilia A Patients (clinicaltrials.gov) -  Jun 7, 2021   
    P=N/A,  N=30, Recruiting, 
    In these patients, no statistical difference was found in ABR[0(0,2) vs. 1(0,2),P =0.62],AJBR [0(0,3) vs. 0(0,4),P =0.63]and ASBR[0(0,2) vs. 0(0,1),P =0.39].Table-1 Table-2 Conclusions : PK-guided prophylaxis could help hemophiliac patients improve quality of life by reducing bleeds with affordable FVIII concentrate consumption as well as decreasing infusion frequency with similar bleeds. Trial completion date: Nov 2021 --> Sep 2022 | Trial primary completion date: May 2021 --> Mar 2022
  • ||||||||||  [VIRTUAL] PHARMACOKINETIC DIFFERENCES IN HEMOPHILIA A BASED ON FVIII PRODUCT AND ON ASSAY TYPE () -  Jan 8, 2021 - Abstract #EAHAD2021EAHAD_16;    
    It is still uncertain whether “Elocta” correlates with higher FVIII levels on CSA and if this fact was relevant for our statistically significant results in t1/2 of EHL in CSA. Interestingly, plasma‐derived product presented higher t1/2 than recombinant products, even though n.s. Although the number of studied patients was low to draft definitive conclusions, making comparison analysis between products more difficult, we observed minimal FVIII measurement discrepancies among OSA and CSA.
  • ||||||||||  Kovaltry (octocog alfa) / Bayer, CSL Behring
    Trial completion:  LEOPOLD Kids: BAY81-8973 Pediatric Safety and Efficacy Trial (clinicaltrials.gov) -  Nov 23, 2020   
    P3,  N=94, Completed, 
    Patients who switched to rVIII-SingleChain prophylaxis reduced dosing frequency and consumption compared with prior treatment, with similar or potentially lower bleeding rates. Active, not recruiting --> Completed
  • ||||||||||  Trial completion:  ATHN 2: Factor Switching Study (clinicaltrials.gov) -  Aug 19, 2020   
    P=N/A,  N=310, Completed, 
    Not yet recruiting --> Recruiting Active, not recruiting --> Completed
  • ||||||||||  Kovaltry (octocog alfa) / Bayer, CSL Behring
    Trial completion date:  LEOPOLD Kids: BAY81-8973 Pediatric Safety and Efficacy Trial (clinicaltrials.gov) -  May 21, 2020   
    P3,  N=94, Active, not recruiting, 
    Recruiting --> Active, not recruiting Trial completion date: Mar 2021 --> Aug 2020
  • ||||||||||  Kovaltry (octocog alfa) / Bayer, CSL Behring
    [VIRTUAL] BAY 81-8973 prophylaxis in Patients with Hemophilia A: Interim Usage and Safety Results from the TAURUS Real-World Study (Virtual Meeting Room 6) -  May 14, 2020 - Abstract #ISTH2020ISTH_849;    
    P=N/A
    In a patient-chart review including four rFVIII products rVIII-SingleChain shows convincing efficacy, real-life ABR (median=0) similar to that observed in clinical studies with a reduced factor consumption, thereby achieving cost-saving while providing excellent patient outcomes. Data analyzed in this interim report confirm a reassuring safety profile and indicate that prophylaxis regimens before and after initiation of BAY 81-8973 were similar and remained stable during the treatment period.
  • ||||||||||  Kovaltry (octocog alfa) / Bayer, CSL Behring
    Trial primary completion date:  LEOPOLD Kids: BAY81-8973 Pediatric Safety and Efficacy Trial (clinicaltrials.gov) -  Feb 26, 2020   
    P3,  N=94, Active, not recruiting, 
    Patients with higher VWF: Ag level or blood type non-O benefit more from the switch. Trial primary completion date: Mar 2021 --> Sep 2019
  • ||||||||||  Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  ATHN 2: Factor Switching Study (clinicaltrials.gov) -  Feb 5, 2020   
    P=N/A,  N=310, Active, not recruiting, 
    Trial primary completion date: Mar 2021 --> Sep 2019 Recruiting --> Active, not recruiting | N=600 --> 310 | Trial completion date: Jan 2022 --> Jun 2020 | Trial primary completion date: Aug 2021 --> Jun 2020
  • ||||||||||  Kovaltry (octocog alfa) / Bayer, CSL Behring
    Bay 81‐8973 prophylaxis in patients with haemophilia A: Interim findings for children <12 years from the TAURUS real‐world study () -  Feb 4, 2020 - Abstract #EAHAD2020EAHAD_416;    
    P=N/A
    Introduction: BAY 81‐8973 (Kovaltry®) is an unmodified, full‐length recombinant factor VIII (FVIII) indicated for prophylaxis and treatment of bleeds in patients of all ages with haemophilia A (HA); its safety and efficacy were established in the LEOPOLD clinical trials...All patients entering the study previously received prophylaxis with FVIII (median 4.5 years), 87.5% had octocog alpha as their most recent treatment (70% were previously treated with Kogenate® FS10% Advate®; 7.5% Helixate®)... Interim results for 40 patients aged <12 years enrolled in the TAURUS real‐world study confirm and extend findings from clinical trials, showing that BAY 81‐8973 provides effective bleeding prophylaxis in previously‐treated paediatric patients with HA.
  • ||||||||||  Afstyla (lonoctocog alfa) / CSL Behring, Advate (octocog alfa) / Takeda
    Prophylactic FVIII treatment regimen and clinical outcomes in german haemophilia a patients: Comparison of rVIII‐SingleChain and other rFVIII products () -  Feb 4, 2020 - Abstract #EAHAD2020EAHAD_414;    
    Haemophilia Treatment Centres provided anonymised patient chart data for 225 patients, 76 with severe haemophilia A. Patients received prophylactic treatment with any of the following rFVIII products for at least 8 weeks – rVIII‐SingleChain (40), rFVIIIFc (47), octocog alfa (58), BAY 81‐8973 (40) and moroctocog alfa (40)... rVIII‐SingleChain demonstrated reduced factor consumption with real‐life ABR (median = 0) similar to that observed in clinical studies, thereby offering potential for cost saving while providing excellent patient outcomes.
  • ||||||||||  Kovaltry (octocog alfa) / Bayer, CSL Behring, Advate (octocog alfa) / Takeda
    Continuous infusion with Kovaltry (octocog alfa) during cardiac surgery for tetralogy of fallot in an hemophilic child () -  Feb 4, 2020 - Abstract #EAHAD2020EAHAD_358;    
    rVIII‐SingleChain demonstrated reduced factor consumption with real‐life ABR (median = 0) similar to that observed in clinical studies, thereby offering potential for cost saving while providing excellent patient outcomes. Our report highlights that CI of BAY 81‐8973 for the hemostatic management of cardiac surgery in pediatric hemophilia patients is safe and effective, with no observed adverse events.
  • ||||||||||  Intra‐individual across‐study comparison of pharmacokinetics of rFVIII‐FS, bay 81‐8973 and bay 94‐9027 in patients with severe haemophilia A () -  Feb 4, 2020 - Abstract #EAHAD2020EAHAD_301;    
    P2/3, P3
    A subset of these patients also participated in the PROTECT VIII trial (NCT01580293), in which the PK profile of BAY 94‐9027 (Jivi®; a B‐domain deleted rFVIII product site‐specifically PEGylated to extend its half‐life) was assessed after a single 60 IU/kg infusion... BAY 94‐9027 demonstrated an extended half‐life compared with both rFVIII‐FS and BAY 81‐8973 following a single infusion in patients with severe haemophilia A. In conclusion, switching treatment from either rFVIII‐FS or BAY 81‐8973 to BAY 94‐9027 is expected to provide improved protection from bleeds and/or allow for less frequent infusions.
  • ||||||||||  NovoEight (turoctocog alfa) / Novo Nordisk, Advate (octocog alfa) / Takeda
    Clinical, Review, Journal:  Status of Recombinant Factor VIII Concentrate Treatment for Hemophilia a in Italy: Characteristics and Clinical Benefits. (Pubmed Central) -  Dec 22, 2019   
    The B domain-truncated (BDT-rFVIII) turoctocog alfa (NovoEight®, Novo Nordisk), the BDD-rFVIII simoctocog alfa (Nuwiq®, Kedrion), the single-chain BDT-rVIII lonoctocog alfa (Afstyla®, CSL Behring), and the BDD-rFVIIIFc efmoroctocog alfa (Elocta®, Sobi-Biogen) are new, innovative products...This review considers the rFVIII products that are indicated for the treatment of patients with severe HA, focusing on those that are commercially available in Italy. Their PK characteristics, immunogenicity, and clinical benefits are discussed and compared.
  • ||||||||||  Kovaltry (octocog alfa) / Bayer, CSL Behring
    Enrollment closed:  LEOPOLD Kids: BAY81-8973 Pediatric Safety and Efficacy Trial (clinicaltrials.gov) -  Sep 6, 2019   
    P3,  N=94, Active, not recruiting, 
    Improved PK for BAY 81-8973 relative to rFVIII-FS and rAHF-PFM as seen in single-dose crossover PK studies might be related to this greater level of branching and sialylation, which can prolong the time BAY 81-8973 remains in the circulation. Recruiting --> Active, not recruiting
  • ||||||||||  Kovaltry (octocog alfa) / Bayer, CSL Behring
    Trial completion date, Trial primary completion date:  LEOPOLD Kids: BAY81-8973 Pediatric Safety and Efficacy Trial (clinicaltrials.gov) -  Aug 28, 2019   
    P3,  N=100, Recruiting, 
    Trial completion date: Apr 2022 --> Dec 2021 Trial completion date: Dec 2022 --> Apr 2021 | Trial primary completion date: Dec 2022 --> Apr 2021