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12 Diseases |  |
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188 News |  |
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- || NovoEight (turoctocog alfa) / Novo Nordisk
Clinical, Journal: Safety and efficacy of turoctocog alfa in the prevention and treatment of bleeds in previously untreated paediatric patients with severe haemophilia A: Results from the guardian 4 multinational clinical trial. (Pubmed Central) - Oct 3, 2020
Turoctocog alfa was effective at preventing and stopping bleeds and was well tolerated. Inhibitor development was within the expected range for this PUP population.
- ||| Trial completion: ATHN 2: Factor Switching Study (clinicaltrials.gov) - Aug 19, 2020
P=N/A, N=310, Completed, Sponsor: American Thrombosis and Hemostasis Network
Inhibitor development was within the expected range for this PUP population. Active, not recruiting --> Completed
- NovoEight (turoctocog alfa) / Novo Nordisk
Trial termination: Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial (clinicaltrials.gov) - Jul 7, 2020
P3, N=1, Terminated, Sponsor: Novo Nordisk A/S
Active, not recruiting --> Completed Completed --> Terminated; The trial was terminated as the participant withdrew from the trial.
- || NovoEight (turoctocog alfa) / Novo Nordisk
Clinical, Journal: Safety and Efficacy of Turoctocog Alfa in the Prevention and Treatment of Bleeding Episodes in Previously Treated Patients from China with Severe Hemophilia A: Results from the Guardian 7 Trial. (Pubmed Central) - Jul 3, 2020
No FVIII inhibitors (≥0.6 BU) were reported. Turoctocog alfa was safe and effective for prophylaxis and treatment of bleeding episodes and for surgery in patients from China with severe hemophilia A across all ages.
- || Alhemo (concizumab) / Novo Nordisk
Trial completion: explorer (clinicaltrials.gov) - Jun 11, 2020
P2, N=36, Completed, Sponsor: Novo Nordisk A/S
Turoctocog alfa was safe and effective for prophylaxis and treatment of bleeding episodes and for surgery in patients from China with severe hemophilia A across all ages. Suspended --> Completed
- NovoEight (turoctocog alfa) / Novo Nordisk
[VIRTUAL] Safety and Efficacy of FVIII Replacement with Turoctocog Alfa in the UK (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_933;
There was no change in ABR or AJBR. Turoctocog alfa has similar efficacy to previous FVIII product in adults and children.
- concizumab (NN7415) / Novo Nordisk, NovoEight (turoctocog alfa) / Novo Nordisk
[VIRTUAL] Concizumab Does Not Affect Activated Partial Thromboplastin Time, Prothrombin Time or Factor VIII/IX Activity Measured Using One-Stage Clotting or Chromogenic Substrate Assays (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_799;
Concizumab did not affect aPTT or PT measurements. Furthermore, concizumab did not affect FVIII or FIX activity measurements using either an OSC or CS assay.
- || NovoEight (turoctocog alfa) / Novo Nordisk
Clinical, PK/PD data, Journal: A comparison of methods for prediction of pharmacokinetics across factor concentrate switching in hemophilia patients. (Pubmed Central) - May 7, 2020
Taking into account individual PK from a previous clotting factor product was shown to provide better means of estimating individual PK for a new product. This may improve regimen design across switches and reduce the time to tailor optimal dose of FVIII products.
- || NovoEight (turoctocog alfa) / Novo Nordisk
Clinical, PK/PD data, Journal: Real Life Population Pharmacokinetics Modelling of Eight Factors VIII in Patients with Severe Haemophilia A: Is It Always Relevant to Switch to an Extended Half-Life? (Pubmed Central) - Apr 25, 2020
This model can be used for all of the FVIII cited in the study. Moreover, we demonstrated, in accordance with previous studies, that Elocta had longer half-life (EHL) than SHL (mean ratio: 1.48) as compared to Advate, Factane, Kogenate, Novoeight, and Refacto.
- | NovoEight (turoctocog alfa) / Novo Nordisk
Journal: The Effect of Fluctuating Temperature on the Stability of Turoctocog Alfa for Hemophilia A. (Pubmed Central) - Apr 23, 2020
The results demonstrated that turoctocog alfa can be subjected to variable storage conditions, including cycling between 5 °C and ≤ 40 °C, and subsequent storage for 3 months up to 40 °C, without loss of stability. This suggests that turoctocog alfa may offer greater product storage flexibility for patients in everyday practice, with a potential reduction in wastage.
- ||| Alhemo (concizumab) / Novo Nordisk
Trial suspension: explorer (clinicaltrials.gov) - Mar 31, 2020
P2, N=36, Suspended, Sponsor: Novo Nordisk A/S
This suggests that turoctocog alfa may offer greater product storage flexibility for patients in everyday practice, with a potential reduction in wastage. Active, not recruiting --> Suspended
- || 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, Sponsor: American Thrombosis and Hemostasis Network
Active, not recruiting --> Suspended Recruiting --> Active, not recruiting | N=600 --> 310 | Trial completion date: Jan 2022 --> Jun 2020 | Trial primary completion date: Aug 2021 --> Jun 2020
- NovoEight (turoctocog alfa) / Novo Nordisk
Experience of UK patients switching to novoeight following national tendering process () - Feb 4, 2020 - Abstract #EAHAD2020EAHAD_533;
Patients surveyed report packaging and storage requirements influence acceptability and satisfaction, recognised to be an important determinant of treatment adherence. Negative comments were influenced by previous experience.
- ||| NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion: guardian (clinicaltrials.gov) - Jan 27, 2020
P=N/A, N=69, Completed, Sponsor: Novo Nordisk A/S
Negative comments were influenced by previous experience. Active, not recruiting --> Completed
- || 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.
- NovoEight (turoctocog alfa) / Novo Nordisk
VWf containing therapeutic concentrates induce FXII activation, leading to kallikrein activation and bradykinin formation in vitro (Lloyd) - Dec 17, 2019 - Abstract #GTH2020GTH_28;
Further research aims to analyse the role of vWF FXII interaction in more detail. Part of the work was supported by a grant of Bayer Vital GmbH, 51368 Leverkusen, Germany
- || NovoEight (turoctocog alfa) / Novo Nordisk
Enrollment closed, Trial completion date, Trial primary completion date: guardian (clinicaltrials.gov) - Dec 3, 2019
P=N/A, N=70, Active, not recruiting, Sponsor: Novo Nordisk A/S
Part of the work was supported by a grant of Bayer Vital GmbH, 51368 Leverkusen, Germany Completed --> Active, not recruiting | Trial completion date: Apr 2019 --> Feb 2020 | Trial primary completion date: Apr 2019 --> Feb 2020
- ||| NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion, Trial completion date, Trial primary completion date: guardian (clinicaltrials.gov) - Dec 2, 2019
P=N/A, N=70, Completed, Sponsor: Novo Nordisk A/S
Completed --> Active, not recruiting | Trial completion date: Apr 2019 --> Feb 2020 | Trial primary completion date: Apr 2019 --> Feb 2020 Enrolling by invitation --> Completed | Trial completion date: Feb 2020 --> Apr 2019 | Trial primary completion date: Feb 2020 --> Apr 2019
- || NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion date, Trial primary completion date: guardian (clinicaltrials.gov) - Nov 26, 2019
P=N/A, N=70, Enrolling by invitation, Sponsor: Novo Nordisk A/S
Enrolling by invitation --> Completed | Trial completion date: Feb 2020 --> Apr 2019 | Trial primary completion date: Feb 2020 --> Apr 2019 Trial completion date: Jun 2020 --> Feb 2020 | Trial primary completion date: Jun 2020 --> Feb 2020
- NovoEight (turoctocog alfa) / Novo Nordisk
Impact of Systematic Pharmacokinetic (PK) Profiles in a Cohort of 29 Patients Treated with Conventional and Extended-Half Life (EHL) Products (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_1931;
Nevertheless, the mean annualized consumption was just 0.6-fold increased in the remaining patients . This approach led us to further reduce ABR and in some cases to obtain a persistent no-bleeding status even with a full active life.
- | NovoEight (turoctocog alfa) / Novo Nordisk
Trial primary completion date: Study Investigating Novoeight (clinicaltrials.gov) - Jul 17, 2019
P=N/A, N=10, Enrolling by invitation, Sponsor: Novo Nordisk A/S
This approach led us to further reduce ABR and in some cases to obtain a persistent no-bleeding status even with a full active life. Trial primary completion date: Jun 2020 --> Jun 2021
- NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion, Trial completion date, Trial primary completion date: Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial (clinicaltrials.gov) - Jul 5, 2019
P3, N=1, Completed, Sponsor: Novo Nordisk A/S
Trial primary completion date: Jun 2020 --> Jun 2021 Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Jun 2019 | Trial primary completion date: May 2021 --> Jun 2019
- || NovoEight (turoctocog alfa) / Novo Nordisk
Enrollment closed: To Investigate Safety and Efficacy of NovoEight (clinicaltrials.gov) - Jun 6, 2019
P=N/A, N=40, Active, not recruiting, Sponsor: Novo Nordisk A/S
Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Jun 2019 | Trial primary completion date: May 2021 --> Jun 2019 Enrolling by invitation --> Active, not recruiting
- ||| NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion, Adverse events: guardian 10: Research Study to Look at Side Effects During Regular Injection With Factor VIII Medicine Named Turoctocog Alfa for a 8 Weeks Period (clinicaltrials.gov) - Apr 24, 2019
P4, N=60, Completed, Sponsor: Novo Nordisk A/S
Enrolling by invitation --> Active, not recruiting Active, not recruiting --> Completed
- NovoEight (turoctocog alfa) / Novo Nordisk
Enrollment closed: Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial (clinicaltrials.gov) - Apr 1, 2019
P3, N=1, Active, not recruiting, Sponsor: Novo Nordisk A/S
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion date, Trial primary completion date: guardian (clinicaltrials.gov) - Feb 11, 2019
P=N/A, N=70, Enrolling by invitation, Sponsor: Novo Nordisk A/S
Recruiting --> Active, not recruiting Trial completion date: Apr 2021 --> Jun 2020 | Trial primary completion date: Apr 2021 --> Jun 2020
- || NovoEight (turoctocog alfa) / Novo Nordisk
Enrollment closed, Adverse events: guardian 10: Research Study to Look at Side Effects During Regular Injection With Factor VIII Medicine Named Turoctocog Alfa for a 8 Weeks Period (clinicaltrials.gov) - Jan 24, 2019
P4, N=60, Active, not recruiting, Sponsor: Novo Nordisk A/S
Trial completion date: Apr 2021 --> Jun 2020 | Trial primary completion date: Apr 2021 --> Jun 2020 Recruiting --> Active, not recruiting
- ||||| NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion: Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A (clinicaltrials.gov) - Jan 14, 2019
P3, N=60, Completed, Sponsor: Novo Nordisk A/S
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- ||||| NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion: guardian TM 7: Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (clinicaltrials.gov) - Jan 3, 2019
P3, N=68, Completed, Sponsor: Novo Nordisk A/S
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | New P4 trial: Implementation of pharmacokinetic-guided dosing of prophylaxis in hemophilia patients. Implementatie van farmacokinetisch gestuurd doseren van profylaxe bij hemofilie patienten. (EUDRACT) - Dec 20, 2018
P4, N=50, , Sponsor: Erasmus University Medical Center
- | NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion date, Trial primary completion date, Adverse events: guardian 10: Research Study to Look at Side Effects During Regular Injection With Factor VIII Medicine Named Turoctocog Alfa for a 8 Weeks Period (clinicaltrials.gov) - Oct 30, 2018
P4, N=60, Recruiting, Sponsor: Novo Nordisk A/S
Active, not recruiting --> Completed Trial completion date: Oct 2019 --> May 2019 | Trial primary completion date: Oct 2019 --> Apr 2019
- | Alhemo (concizumab) / Novo Nordisk
Trial completion date: explorer (clinicaltrials.gov) - Sep 11, 2018
P2, N=33, Active, not recruiting, Sponsor: Novo Nordisk A/S
Trial completion date: Oct 2019 --> May 2019 | Trial primary completion date: Oct 2019 --> Apr 2019 Trial completion date: Aug 2019 --> Mar 2020
- | NovoEight (turoctocog alfa) / Novo Nordisk
Enrollment status, Trial completion date, Trial primary completion date: To Investigate Safety and Efficacy of NovoEight (clinicaltrials.gov) - Aug 13, 2018
P=N/A, N=35, Enrolling by invitation, Sponsor: Novo Nordisk A/S
Trial completion date: Aug 2019 --> Mar 2020 Recruiting --> Enrolling by invitation | Trial completion date: Aug 2020 --> Feb 2021 | Trial primary completion date: Aug 2020 --> Feb 2021
- | NovoEight (turoctocog alfa) / Novo Nordisk
Trial primary completion date: guardian (clinicaltrials.gov) - Aug 7, 2018
P=N/A, N=70, Enrolling by invitation, Sponsor: Novo Nordisk A/S
Recruiting --> Enrolling by invitation | Trial completion date: Aug 2020 --> Feb 2021 | Trial primary completion date: Aug 2020 --> Feb 2021 Trial primary completion date: Apr 2018 --> Apr 2021
- | NovoEight (turoctocog alfa) / Novo Nordisk
New P3 trial: Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial (clinicaltrials.gov) - Jul 16, 2018
P3, N=1, Recruiting, Sponsor: Novo Nordisk A/S
- | NovoEight (turoctocog alfa) / Novo Nordisk
Enrollment open, Trial completion date: Study Investigating Novoeight (clinicaltrials.gov) - Jul 6, 2018
P=N/A, N=8, Enrolling by invitation, Sponsor: Novo Nordisk A/S
Trial primary completion date: Apr 2018 --> Apr 2021 Not yet recruiting --> Enrolling by invitation | Trial completion date: Jun 2020 --> Jun 2021
- |||| NovoEight (turoctocog alfa) / Novo Nordisk
Enrollment open, Adverse events: guardian 10: Research Study to Look at Side Effects During Regular Injection With Factor VIII Medicine Named Turoctocog Alfa for a 8 Weeks Period (clinicaltrials.gov) - Mar 5, 2018
P4, N=60, Recruiting, Sponsor: Novo Nordisk A/S
Not yet recruiting --> Enrolling by invitation | Trial completion date: Jun 2020 --> Jun 2021 Not yet recruiting --> Recruiting
- NovoEight (turoctocog alfa) / Novo Nordisk
Trial primary completion date: guardian (clinicaltrials.gov) - Mar 3, 2018
P1, N=35, Completed, Sponsor: Novo Nordisk A/S
Not yet recruiting --> Recruiting Trial primary completion date: Jun 2017 --> Jun 2017
- ||||| NovoEight (turoctocog alfa) / Novo Nordisk
New P4 trial, Adverse events: guardian 10: Research Study to Look at Side Effects During Regular Injection With Factor VIII Medicine Named Turoctocog Alfa for a 8 Weeks Period (clinicaltrials.gov) - Feb 27, 2018
P4, N=60, Not yet recruiting, Sponsor: Novo Nordisk A/S
- |||| NovoEight (turoctocog alfa) / Novo Nordisk
Trial primary completion date: guardian TM 7: Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (clinicaltrials.gov) - Feb 26, 2018
P3, N=65, Active, not recruiting, Sponsor: Novo Nordisk A/S
Trial primary completion date: Jun 2017 --> Jun 2017 Trial primary completion date: Dec 2018 --> Apr 2018
- NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion date, Trial initiation date: Study Investigating Novoeight (clinicaltrials.gov) - Feb 6, 2018
P=N/A, N=8, Not yet recruiting, Sponsor: Novo Nordisk A/S
Trial primary completion date: Dec 2018 --> Apr 2018 Initiation date: Dec 2017 --> Mar 2018 | Trial completion date: Jun 2020 --> Jun 2020
- | Alhemo (concizumab) / Novo Nordisk
Enrollment closed: explorer (clinicaltrials.gov) - Jan 16, 2018
P2, N=33, Active, not recruiting, Sponsor: Novo Nordisk A/S
Initiation date: Dec 2017 --> Mar 2018 | Trial completion date: Jun 2020 --> Jun 2020 Recruiting --> Active, not recruiting
- |||| NovoEight (turoctocog alfa) / Novo Nordisk
Trial primary completion date: Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A (clinicaltrials.gov) - Jan 11, 2018
P3, N=60, Active, not recruiting, Sponsor: Novo Nordisk A/S
Recruiting --> Active, not recruiting Trial primary completion date: Feb 2017 --> Aug 2017
- ||||| NovoEight (turoctocog alfa) / Novo Nordisk
Enrollment closed: guardian TM 7: Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (clinicaltrials.gov) - Dec 4, 2017
P3, N=65, Active, not recruiting, Sponsor: Novo Nordisk A/S
Trial primary completion date: Feb 2017 --> Aug 2017 Recruiting --> Active, not recruiting
- NovoEight (turoctocog alfa) / Novo Nordisk
Trial initiation date: Study Investigating Novoeight (clinicaltrials.gov) - Oct 4, 2017
P=N/A, N=8, Not yet recruiting, Sponsor: Novo Nordisk A/S
Recruiting --> Active, not recruiting Initiation date: Jun 2017 --> Dec 2017
- | Alhemo (concizumab) / Novo Nordisk
Enrollment open: explorer (clinicaltrials.gov) - Aug 22, 2017
P2, N=33, Recruiting, Sponsor: Novo Nordisk A/S
Initiation date: Jun 2017 --> Dec 2017 Not yet recruiting --> Recruiting
- | NovoEight (turoctocog alfa) / Novo Nordisk
Trial completion: guardian (clinicaltrials.gov) - Jul 27, 2017
P1, N=35, Completed, Sponsor: Novo Nordisk A/S
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- | Alhemo (concizumab) / Novo Nordisk
New P2 trial: explorer (clinicaltrials.gov) - Jun 22, 2017
P2, N=33, Not yet recruiting, Sponsor: Novo Nordisk A/S
- NovoEight (turoctocog alfa) / Novo Nordisk
New trial: Study Investigating Novoeight (clinicaltrials.gov) - Jun 7, 2017
P=N/A, N=8, Not yet recruiting, Sponsor: Novo Nordisk A/S
- NovoEight (turoctocog alfa) / Novo Nordisk
Enrollment closed: guardian (clinicaltrials.gov) - May 31, 2017
P1, N=35, Active, not recruiting, Sponsor: Novo Nordisk A/S
Active, not recruiting --> Completed Recruiting --> Active, not recruiting