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- The Influence of Coagulation Factor Biosimilars in Shortening the Activated Partial Thromboplastin Time in Patients with Hemophilia a () - Dec 7, 2024 - Abstract #ASH2024ASH_7560;
Negative correlation was observed between PT and FVII values after adding Kogenate FS (r=-0.103, p<0.001), aPTT and FVIII values after adding Kogenate FS (r=-0.898, p<0.001), aPTT and FVIII values after adding NovoEight (r=-0.865, p<0.001), as well as aPTT and FVIII values after adding AryoSeven (r=-0.647, p<0.001).Conclusion : All the investigated drugs significantly shorten aPTT values and increase values of FVIII and FVII. In terms of efficacy, no difference exists between AryoSeven and NovoSeven, as well as between Kogenate FS and NovoEight only in altering PT.
- | NovoEight (turoctocog alfa) / Novo Nordisk
Journal: Continuous Infusion of Turoctocog Alfa in Patients With Mild to Moderate Hemophilia A: A Case Series. (Pubmed Central) - Sep 18, 2024
In terms of efficacy, no difference exists between AryoSeven and NovoSeven, as well as between Kogenate FS and NovoEight only in altering PT. No abstract available
- |||||| NovoEight (turoctocog alfa) / Novo Nordisk
New trial: Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients (clinicaltrials.gov) - Aug 28, 2024
P=N/A, N=900, Not yet recruiting, Sponsor: Novo Nordisk A/S
- NovoEight (turoctocog alfa) / Novo Nordisk, Kogenate FS (octocog alfa sucrose formulation) / CSL Behring, Bayer
Comparison of Coagulation Factor VIII Biosimilars (Kogenate FS Vs NovoEight) in Altering Prothrombin Time, activated Partial Thromboplastin Time, and levels of Factors VII and VIII in Hemophilia A (Exhibition Hall) - May 17, 2024 - Abstract #ISTH2024ISTH_1768;
A negative correlation was observed between PT and FVII values after adding Kogenate FS (r=-0.103, p< 0.001), aPTT and FVIII values after adding Kogenate FS (r=-0.898, p< 0.001), aPTT and FVIII values after adding NovoEight (r=-0.865, p< 0.001). Conclusion(s) : These investigated drugs significantly shorten aPTT values and increase values of FVIII and FVII.
- Alhemo (concizumab) / Novo Nordisk
Comparison of FVIII and concizumab in thrombin generation assays under different conditions (Exhibition Hall) - May 17, 2024 - Abstract #ISTH2024ISTH_932;
Conclusion(s) : These investigated drugs significantly shorten aPTT values and increase values of FVIII and FVII. Under these conditions, FVIII (NovoEight, Novo Nordisk; 0.03
- Mim8 / Novo Nordisk
ACCURATE MEASUREMENT OF FACTOR VIII ACTIVITY AND INHIBITORS IN THE PRESENCE OF MIM8 (Riverwalk AB; Virtual) - Mar 2, 2024 - Abstract #THSNA2024THSNA_290;
Under these conditions, FVIII (NovoEight, Novo Nordisk; 0.03 To assess FVIII activity of SHL and EHL products, severe HA plasma was spiked with ADVATE
- | Eloctate (efraloctocog alfa) / Sanofi, SOBI, NovoEight (turoctocog alfa) / Novo Nordisk, Jivi (damoctocog alfa pegol) / Bayer
Journal: Variability in combinations of APTT reagent and substrate plasma for a one-stage clotting assay to measure factor VIII products. (Pubmed Central) - Mar 1, 2024
In addition to APTT reagents, variations in F8DPs used for OSAs can also affect FVIII:C results. F8DPs as well as the APTT reagent used for OSA should be chosen with caution, and laboratories should evaluate reagents for F8DPs as they currently do for APTT reagents, especially when lot changes occur.
- || NovoEight (turoctocog alfa) / Novo Nordisk
P4 data, Journal, Real-world evidence, Real-world: Real-world long-term safety and effectiveness of turoctocog alfa in the treatment of haemophilia A in Japan: results from a multicentre, non-interventional, post-marketing study. (Pubmed Central) - Feb 24, 2024
The effectiveness and safety profiles were comparable to those observed in other turoctocog alfa trials; effectiveness analysis and consumption were not affected by treatment regimens. Long-term use of turoctocog alfa therapy in clinical practice posed no newly identified safety issues and was effective for prophylaxis and treatment of bleeds in patients with haemophilia A in Japan.
- | NovoEight (turoctocog alfa) / Novo Nordisk
Retrospective data, Journal: Efficacy and safety of turoctocog alfa in patients with hemophilia A requiring surgical procedures: A multicentre retrospective study. (Pubmed Central) - Dec 7, 2023
Long-term use of turoctocog alfa therapy in clinical practice posed no newly identified safety issues and was effective for prophylaxis and treatment of bleeds in patients with haemophilia A in Japan. The efficacy and safety of turoctocog alfa were confirmed for the management of surgery in patients with hemophilia A. No adverse events were observed and overall efficacy was good.
- ||||||| NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion, Enrollment change: THIRd: Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities (clinicaltrials.gov) - Nov 28, 2023
P=N/A, N=18, Completed, Sponsor: Novo Nordisk A/S
The efficacy and safety of turoctocog alfa were confirmed for the management of surgery in patients with hemophilia A. No adverse events were observed and overall efficacy was good. Enrolling by invitation --> Completed | N=75 --> 18
- Nuwiq (simoctocog alfa) / Octapharma, NovoEight (turoctocog alfa) / Novo Nordisk
Matching Adjusted Indirect Comparisons Between Personalized Prophylaxis with Simoctocog Alfa versus Standard Prophylaxis with Turoctocog Alfa in Adults with Severe Hemophilia A (Room:Exhibition) - May 18, 2023 - Abstract #ISTH2023ISTH_1896;
- | Journal: Area under the curve: Comparing the value of factor VIII replacement therapies in haemophilia A. (Pubmed Central) - Nov 30, 2022
This analysis concludes that EHL products differ in relative AUC, have a larger AUC compared with standard half-life, and thus, different FVIII levels over time after infusion. This model may aid decision makers in the absence of head-to-head data.
- | NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Surgery: SERAPHINE: Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight (clinicaltrials.gov) - Nov 25, 2022
P=N/A, N=60, Completed, Sponsor: Nantes University Hospital
This model may aid decision makers in the absence of head-to-head data. Recruiting --> Completed | N=100 --> 60 | Trial completion date: Apr 2022 --> Jun 2022 | Trial primary completion date: Apr 2022 --> Dec 2021
- | NovoEight (turoctocog alfa) / Novo Nordisk, Advate (octocog alfa) / Takeda
Journal: Methods for anti-factor VIII antibody levels in haemophilia A patients - validation of a multiplex immunoassay and comparability with assays measuring non-neutralising and neutralising antibodies (inhibitors). (Pubmed Central) - Oct 5, 2022
Actual NNA titers are determined to both full-length and B-domain deleted FVIII. The xFLI is thus valuable for confirmation of all anti-FVIII antibodies.
- Abstilla (lonoctocog alfa) / CSL Behring
A Cost Minimization Model of Afsteyela® (Lonoctocog-Alfa) for the Prophylactic Treatment of Pediatric Patients With Haemophilia A, in Mexico (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1749;
A cost-minimization model (fo anual costs) was developed to estimate the treatment cost associated with lonoctocog-alfa, compared to turoctocog-alfa, moroctocog-alfa, octocog-alfa and simoctocog-alfa in pediatric patients with severe Haemophilia-A. For the treatment of patients with severe Haemophilia-A in Mexico, lonoctocog-alfa was a cost-saving option compared to existing rFVII in Mexico from the public payer perspective.
- Jivi (damoctocog alfa pegol) / Bayer
Cost-Minimization Analysis of Damoctocog Alfa Pegol With the Treatment of Hemophilia A in Turkey (Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_769;
OBJECTIVES: To compare the lifetime consumption and cost of an extended-half liferecombinant factor VIII (rFVIII), the damoctocog alfa pegol, with reimbursed standard half life (SHL) factors (octocog alfa, moroctocog alfa, turoctocog alfa) for the treatment of haemophilia A (HemA) in patients with age ≥ 12 years in Turkey, from the public payer perspective. From the perspective of the public payer, damoctocog alfa pegol demonstrated good efficacy while being the lowest cost-generating option for the treatment of HemA patients in Turkey, when compared to existing reimbursed SHLs.
- Performance of FVIII deficient plasma with VWF in the activity measurement of FVIII replacement products in plasma samples using an OSC assay. (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_2150;
Mean FVIII% recoveries across all levels of Advate, Eloctate, Jivi, Novoeight and Wilate were 93, 95, 101, 113 and 95% respectively. The percent recoveries of Afstyla, after x2 conversion, fell within the acceptance criteria for levels of ≥ 0.1 IU/mL but over-estimated at 149.76% at the lowest level of 0.05 IU/mL.
- NovoEight (turoctocog alfa) / Novo Nordisk
Cost Minimization Analysis Evaluating Turoctocog ALFA (NOVOEIGHT®) and Product X As Prophylaxis Treatment for Paediatric and Adult Patients with Severe Haemophilia a in China (Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_690;
The percent recoveries of Afstyla, after x2 conversion, fell within the acceptance criteria for levels of ≥ 0.1 IU/mL but over-estimated at 149.76% at the lowest level of 0.05 IU/mL. Compared with product X, using Novoeight ® as prophylaxis treatment was likely to reduce the total annual costs both for prophylaxis and breakthrough bleeds treatment in paediatric and adult patients with severe haemophilia A in China.
- Hemlibra (emicizumab-kxwh) / Roche, NovoEight (turoctocog alfa) / Novo Nordisk
Impact of Prophylactic Therapy on Health Related Quality of Life (HRQOL) of Children with Hemophilia a without Inhibitors: A Systematic Review and Meta-Regression Analysis (Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_366;
After title and abstract screening, 98 studies were retrieved for full text reading, of which 14 studies (778 patients from 12 countries) met the inclusion criteria for the meta-regression analysis. The proportion of patients on prophylactic treatment ranged from 0% to 100% of patients on a prophylactic regimen with regular administration of FVIII (11 studies), turoctocog alfa (two studies), or emicizumab (one study).
- NovoEight (turoctocog alfa) / Novo Nordisk
EVALUATION OF CAI'S FORMULA IN CHINESE PREVIOUSLY TREATED PATIENTS WITH SEVERE HEMOPHILIA A RECEIVING TUROCTOCOG ALFA ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_244;
P3
The proportion of patients on prophylactic treatment ranged from 0% to 100% of patients on a prophylactic regimen with regular administration of FVIII (11 studies), turoctocog alfa (two studies), or emicizumab (one study). Cai's Formula provided similar T1/2-C as T1/2-G for Turoctocog alfa in PTP with severe HA >12y.SD of T1/2-C was comparatively low which verified that Cai's Formula could be used to estimate T1/2 and simulate the phase III FVIII activity curve by using only 2 blood samples.So, it could potentially guide individualized prophylaxis of severe HA.
- NovoEight (turoctocog alfa) / Novo Nordisk
EFFICACY AND SAFETY OF TUROCTOCOG ALFA IN PATIENTS WITH HAEMOPHILIA A REQUIRING SURGICAL PROCEDURES: A FRENCH SINGLE CENTRE RETROSPECTIVE STUDY ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_238;
Cai's Formula provided similar T1/2-C as T1/2-G for Turoctocog alfa in PTP with severe HA >12y.SD of T1/2-C was comparatively low which verified that Cai's Formula could be used to estimate T1/2 and simulate the phase III FVIII activity curve by using only 2 blood samples.So, it could potentially guide individualized prophylaxis of severe HA. This retrospective real-life cohort confirms the efficacy and safety of turoctocog alfa in the management of major and minor surgeries in patients with haemophilia A. No adverse events and an overall good efficiency were observed.
- AREA UNDER THE CURVE: INDIRECT PRODUCT COMPARISONS BETWEEN FACTOR VIII REPLACEMENT THERAPIES IN HAEMOPHILIA A ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_221;
In Scenarios 1 and 3, Jivi showed the largest AUC, and in Scenario 2, AUCs of EHLs Elocta and Adynovi were larger than Advate. This AUC tool may aid decision makers in comparing the relative value of FVIII concentrates in the absence of head-to-head trials.
- NovoEight (turoctocog alfa) / Novo Nordisk, Esperoct (turoctocog alfa pegol) / Novo Nordisk
POST-INFUSION MONITORING OF FVIII REPLACEMENT THERAPY – DATA FROM THE UK NEQAS BC EQA PROGRAMME 2021 ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_203;
The difference in measurement between assays for Esperoct would almost certainly be clinically relevant. No specific reagent recommendations are made for monitoring treatment with Novoeight.
- || NovoEight (turoctocog alfa) / Novo Nordisk
Clinical, Observational data, Journal: Zero incidence of factor VIII inhibitors and successful haemostatic response in previously factor VIII-treated patients with haemophilia A switching to turoctocog alfa in a noninterventional study. (Pubmed Central) - Jan 14, 2022
No specific reagent recommendations are made for monitoring treatment with Novoeight. Turoctocog alfa was safe and efficacious for haemophilia A treatment in routine clinical practice.
- || Tresiba (insulin degludec) / Novo Nordisk
Clinical, Journal: Calibration-free concentration analysis for quantification of anti-drug specific antibodies in polyclonal positive control antibodies and in clinical samples. (Pubmed Central) - Nov 10, 2021
Moreover, we effectively quantified serum anti-insulin antibodies in high-titre clinical samples from individuals with diabetes mellitus. This application extends the relevance of the CFCA technology to analysis of immunogenicity for accurate quantification of ADAs in both the polyclonal positive control and in clinical samples.
- Eloctate (efraloctocog alfa) / Sanofi, SOBI, NovoEight (turoctocog alfa) / Novo Nordisk, Advate (octocog alfa) / Takeda
GPVI is a binding partner for pro-coagulant factor VIII on platelets () - Oct 18, 2021 - Abstract #ECTH2021ECTH_65;
Our recent data identify GPVI as a novel binding partner for FVIII on platelets. The interaction involves the C1 and C2 domains of the light chain of FVIII and is prevented in the presence of VWF.
- | Journal: Validation of factor VIII activity for monitoring standard and extended half-life products and correlation to thrombin generation assays. (Pubmed Central) - Sep 22, 2021
Our data revealed good correlation and acceptable bias between CSA and OSA using our sets of reagents, methods and analyser in spiked samples. Thrombin generation gave good correlation to CSA-1 factor activity and is a possible complement to factor activity assays.
- || NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion date, Trial primary completion date: THIRd: Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities (clinicaltrials.gov) - Sep 16, 2021
P=N/A, N=75, Enrolling by invitation, Sponsor: Novo Nordisk A/S
Thrombin generation gave good correlation to CSA-1 factor activity and is a possible complement to factor activity assays. Trial completion date: Aug 2022 --> Mar 2023 | Trial primary completion date: Aug 2022 --> Mar 2023
- | NovoEight (turoctocog alfa) / Novo Nordisk
Enrollment open, Surgery: SERAPHINE: Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight (clinicaltrials.gov) - Aug 26, 2021
P=N/A, N=100, Recruiting, Sponsor: Nantes University Hospital
Trial completion date: Aug 2022 --> Mar 2023 | Trial primary completion date: Aug 2022 --> Mar 2023 Not yet recruiting --> Recruiting
- || NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion: Study Investigating Novoeight (clinicaltrials.gov) - Aug 16, 2021
P=N/A, N=10, Completed, Sponsor: Novo Nordisk A/S
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- NovoEight (turoctocog alfa) / Novo Nordisk, Advate (octocog alfa) / Takeda
[VIRTUAL] GPVI, a New Binding Partner for pro-coagulant Factor VIII on Platelets (Room 1) - Jun 9, 2021 - Abstract #ISTH2021ISTH_2322;
The present findings identify GPVI as a novel binding partner for FVIII light chain on platelets; the interaction is however prevented in the presence of VWF. Future work will decipher the domains of GPVI implicated in FVIII binding and the potential biological significance of the interaction.
- NovoEight (turoctocog alfa) / Novo Nordisk, Advate (octocog alfa) / Takeda
[VIRTUAL] GPVI, a New Binding Partner for pro-coagulant Factor VIII on Platelets (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_1417;
The present findings identify GPVI as a novel binding partner for FVIII light chain on platelets; the interaction is however prevented in the presence of VWF. Future work will decipher the domains of GPVI implicated in FVIII binding and the potential biological significance of the interaction.
- | Journal: Quantitative HLA-class-II/Factor VIII (FVIII) Peptidomic Variation in Dendritic Cells Correlates with the Immunogenic Potential of Therapeutic FVIII Proteins in Hemophilia A. (Pubmed Central) - May 15, 2021
Future work will decipher the domains of GPVI implicated in FVIII binding and the potential biological significance of the interaction. Our results provide HLAcII peptidomic level explanations for several important clinical observations/issues including the differential immunogenicity of distinct FVIIIs and the role of HLAcII genetics in inhibitor development.
- ||| NovoEight (turoctocog alfa) / Novo Nordisk
Enrollment open: THIRd: Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities (clinicaltrials.gov) - Apr 29, 2021
P=N/A, N=75, Enrolling by invitation, Sponsor: Novo Nordisk A/S
Our results provide HLAcII peptidomic level explanations for several important clinical observations/issues including the differential immunogenicity of distinct FVIIIs and the role of HLAcII genetics in inhibitor development. Not yet recruiting --> Enrolling by invitation
- | NovoEight (turoctocog alfa) / Novo Nordisk
Enrollment closed: Study Investigating Novoeight (clinicaltrials.gov) - Apr 14, 2021
P=N/A, N=10, Active, not recruiting, Sponsor: Novo Nordisk A/S
Not yet recruiting --> Enrolling by invitation Enrolling by invitation --> Active, not recruiting
- Eloctate (efraloctocog alfa) / Sanofi, SOBI, NovoEight (turoctocog alfa) / Novo Nordisk, Adynovate (rurioctocog alfa pegol) / Nektar Therapeutics, Takeda
[VIRTUAL] Extended Half-Life (EHL) Recombinant Factor VIII (RFVIII) for the Treatment of Hemophilia a in Italy- Cost of Treatment Comparison () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_1167;
RESULTS : Compared to turoctocog alfa and efmoroctocog alfa, rurioctocog alfa pegol is the drug associated with the lowest mean annual IU consumption: 4,343 IU for rurioctocog alfa pegol, 4,550 IU for turoctocog alfa and 4,878 IU for efmoroctocog alfa. DiseaseRare and Orphan Diseases
- | NovoEight (turoctocog alfa) / Novo Nordisk
New trial, Surgery: SERAPHINE: Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight (clinicaltrials.gov) - Mar 21, 2021
P, N=100, Not yet recruiting, Sponsor: Nantes University Hospital
- NovoEight (turoctocog alfa) / Novo Nordisk
[VIRTUAL] Safety and efficacy of turoctocog alfa in severe and moderately severe previously treated patients with haemophilia A: interim results after >4,000 exposure days (guardian 5) (PARALLEL SESSION HALL A) - Mar 21, 2021 - Abstract #OSHC2020OSHC_108;
- ||| NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion: To Investigate Safety and Efficacy of NovoEight (clinicaltrials.gov) - Mar 4, 2021
P=N/A, N=40, Completed, Sponsor: Novo Nordisk A/S
DiseaseRare and Orphan Diseases Active, not recruiting --> Completed
- || NovoEight (turoctocog alfa) / Novo Nordisk
Trial primary completion date: THIRd: Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities (clinicaltrials.gov) - Feb 11, 2021
P=N/A, N=75, Not yet recruiting, Sponsor: Novo Nordisk A/S
Active, not recruiting --> Completed Trial primary completion date: Sep 2021 --> Aug 2022
- || NovoEight (turoctocog alfa) / Novo Nordisk
Clinical, Journal: An evaluation of the safety and efficacy of turoctocog alfa for hemophilia A. (Pubmed Central) - Feb 4, 2021
Turoctocog alfa (NovoEight®, Novo Nordisk A/S, Bagsvaerd, Denmark) was the first third-generation B-domain truncated recombinant FVIII.Areas covered: The manuscript describes the characteristics of turoctocog alfa, as well as its efficacy and safety for prophylaxis and on-demand treatment for patients with severe hemophilia A without inhibitors.Expert opinion: In clinical trials, turoctocog alfa has demonstrated very good efficacy and safety for the prophylaxis and on-demand treatment of hemophilia A patients, as well as high hemostatic activity during surgery and in managing bleeding episodes. Post-marketing studies and real-life data are anticipated to further reinforce the value of long-term prophylaxis, and estimate the incidence of inhibitors to FVIII.
- NovoEight (turoctocog alfa) / Novo Nordisk
[VIRTUAL] ZERO INCIDENCE OF FACTOR VIII INHIBITORS AND SUCCESSFUL HAEMOSTATIC RESPONSE IN PREVIOUSLY FACTOR VIII‐TREATED HAEMOPHILIA A PATIENTS SWITCHING TO TUROCTOCOG ALFA IN A NON‐INTERVENTIONAL STUDY () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_202;
P=N/A
Turoctocog alfa was safe and efficacious for treatment in routine clinical practice. Results aligned with previous guardian trials.
- [VIRTUAL] IN‐HOUSE VALIDATION OF FACTOR VIII ACTIVITY FOR STANDARD AND EXTENDED HALF‐LIFE PRODUCTS AND CORRELATION TO THROMBIN GENERATION ASSAYS () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_11;
The CSA‐1 method gave the least variability compared to the assigned values. In addition, thrombin generation using spiked samples gave excellent correlation to CSA factor activity and identified a thrombin generation method with greater sensitivity towards FVIII in terms of dose response in lag time.
- || NovoEight (turoctocog alfa) / Novo Nordisk
Clinical, Journal: Body Mass Index Best Predicts Recovery of Recombinant Factor VIII in Underweight to Obese Patients with Severe Haemophilia A. (Pubmed Central) - Dec 18, 2020
BMI appears to be the best predictor of recombinant FVIII recovery; however, PK endpoints were also dependent on other body composition variables. The model demonstrated that dosing can be adjusted for individual BMI to achieve better FVIII predictability across BMI categories.
- || NovoEight (turoctocog alfa) / Novo Nordisk
Clinical, Journal: Turoctocog alfa is safe for the treatment of Indian patients with hemophilia A: Guardian 10 trial results. (Pubmed Central) - Dec 17, 2020
The hemostatic success rate for the treatment of bleeding episodes with turoctocog alfa was 81.6%. The trial results demonstrated that turoctocog alfa is a safe treatment option for the prophylaxis and treatment of bleeding episodes in previously treated adolescent and adult patients with hemophilia A in the Indian population.
- | NovoEight (turoctocog alfa) / Novo Nordisk
Preclinical, Journal: Stability of Turoctocog Alfa, a Recombinant Factor VIII Product, during Continuous Infusion In Vitro. (Pubmed Central) - Nov 18, 2020
Potency was within the prespecified acceptance limits throughout 24 hours of infusion. These findings confirm the suitability of turoctocog alfa for CI.
- NovoEight (turoctocog alfa) / Novo Nordisk
[VIRTUAL] Weight-Based Dosing in Hemophilia a: A Randomized, Controlled, Open-Label, Crossover Trial to Measure Factor VIII Recovery Following Factor VIII Concentrate Dosing Based on Total Body Weight, Ideal Body Weight, and Lean Body Mass (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_3498;
This primarily affected IBW and LBM-based dosing, which may have served to reduce the effect size above. In conclusion, based on these findings, overweight and obese patients with hemophilia A should undergo individualized pharmacokinetic studies using alternative descriptors of body weight to determine the most accurate, and cost-effective, method of achieving targeted FVIII recovery values.
- [VIRTUAL] FEIBA® and Novoseven® Neutralize the Anticoagulant Effects of a Novel Small Molecule FXIa Inhibitor BMS-986177/JNJ-70033093 in Human Plasma and Whole Blood in Vitro (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_2272;
These results demonstrate that FEIBA® and NovoSeven® can effectively neutralize the anticoagulant effects of BMS-177/JNJ-3093 in vitro. A clinical study is required to determine if these agents can reverse the anticoagulant effects of BMS-177/JNJ-3093 in patients.
- | NovoEight (turoctocog alfa) / Novo Nordisk
Journal: Monitoring standard and extended half-life products in hemophilia: Assay discrepancies for factor VIII and IX in pre- and postinfusion samples. (Pubmed Central) - Nov 3, 2020
Samples containing FVIII products (NovoEight, Elocta, and Nuwiq) gave higher levels when measured with CSA compared to OSA...Samples containing Alprolix, a FIX product, gave a smaller difference between activity levels (CSA-OSA), and the correlation was excellent (r = .96)...These discrepancies indicate the value of having more than one type of assay available in the coagulation laboratory when monitoring hemophilia treatment with extended half-life products. Global assays gave complementary information indicated by the modest correlations to factor activities.
- |||||| NovoEight (turoctocog alfa) / Novo Nordisk
New trial: THIRd: Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities (clinicaltrials.gov) - Oct 12, 2020
P, N=75, Not yet recruiting, Sponsor: Novo Nordisk A/S