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- sildenafil / Generic mfg.
[VIRTUAL] GENEration Next: Gene Therapy and Non-Factor Therapeutics for Hemophilia () - Mar 9, 2021 - Abstract #HOPA2021HOPA_41;
During this session, both FDA-approved and investigational non-factor therapeutics will be explored along with the fundamentals of gene therapy as it relates to hemophilia. Hematology/oncology pharmacists should be able to walk away from this session with an enhanced understanding of the next generation of therapeutics for hemophilia.
- | Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
Journal: The availability of new drugs for hemophilia treatment. (Pubmed Central) - Jan 29, 2021
Great attention must be paid to the dangerous synergy of APCC and emicizumab, responsible for some fatal events during the clinical trials and compassionate use of this drug. So far, replacement therapy should be the standard of care for hemophilia patients without inhibitors or difficulties in venous access.
- concizumab (NN7415) / Novo Nordisk
[VIRTUAL] SAFETY AND LONGER‐TERM EFFICACY OF CONCIZUMAB PROPHYLAXIS IN PATIENTS WITH HAEMOPHILIA A OR B WITH INHIBITORS: RESULTS FROM THE EXTENSION PART OF THE PHASE 2 EXPLORER4 TRIAL (Room: EAHAD Virtual Congress) - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_392;
P2
So far, replacement therapy should be the standard of care for hemophilia patients without inhibitors or difficulties in venous access. Results from this analysis of the combined main and extension parts of explorer4 support the clinical proof‐of‐concept established in the main part, and longer‐term safety and efficacy of concizumab as a subcutaneous treatment for patients with HAwI and HBwI.
- concizumab (NN7415) / Novo Nordisk, NovoSeven (eptacog alfa) / Novo Nordisk, Feiba (human plasma derived anti-inhibitor coagulant complex) / Takeda
[VIRTUAL] EVALUATION OF THERAPEUTIC OPTIONS FOR PATIENTS WITH FACTOR VII DEFICIENCY USING GLOBAL COAGULATION ASSAYS () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_235;
The effect of in vitro spiking of rFVIIa (Novoseven), aPCC (Feiba) and anti‐TFPI (clone mAb2021, Creative Biolabs) were assessed by thromboelastometry (ROTEM) and Calibrated Automated Thrombogram (CAT). TFPI inhibition seemed to produce a procoagulant effect in FVII deficient samples opening the idea of its usage as an alternative treatment for patients with FVII deficiency with inhibitors.
- concizumab (NN7415) / Novo Nordisk
[VIRTUAL] RISK MITIGATION STRATEGY FOR CONCIZUMAB CLINICAL TRIALS RE‐INITIATION AFTER PAUSE DUE TO NON‐FATAL THROMBOTIC EVENTS () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_182;
P3
TFPI inhibition seemed to produce a procoagulant effect in FVII deficient samples opening the idea of its usage as an alternative treatment for patients with FVII deficiency with inhibitors. After assessing all available data, Novo Nordisk defined strategies for risk mitigation and made amendments to the phase 3 explorer trial protocols, allowing the re‐initiation of the explorer7 and explorer8 trials.
- concizumab (NN7415) / Novo Nordisk
[VIRTUAL] PATIENT RECEIVING PROPHYLAXIS WITH CONCIZUMAB AND UNDERGOING MINOR SURGERY: A CASE REPORT () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_150;
P2
Rurioctocog alfa pegol (Adynovate®) 20 IU/kg was administered one hour before surgery and was repeated at 24 and 48 hours, maintaining the daily prophylaxis with concizumab. Our data indicate that concizumab combined with low‐dose FVIII is effective and has a good safety profile for controlling bleeding in patients with severe hemophilia A without inhibitor receiving prophylaxis with concizumab and undergoing minor surgery.
- concizumab (NN7415) / Novo Nordisk
[VIRTUAL] LONGER‐TERM EFFICACY AND SAFETY OF CONCIZUMAB PROPHYLAXIS IN PATIENTS WITH SEVERE HAEMOPHILIA A WITHOUT INHIBITORS: RESULTS FROM THE EXTENSION PART OF THE PHASE 2 EXPLORER5 TRIAL () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_135;
P2
Our data indicate that concizumab combined with low‐dose FVIII is effective and has a good safety profile for controlling bleeding in patients with severe hemophilia A without inhibitor receiving prophylaxis with concizumab and undergoing minor surgery. Results from the combined main and extension parts of explorer5 support the clinical proof of concept established in the main part of the trial and provided details of the longer‐term efficacy and safety of subcutaneous prophylactic treatment with concizumab in HA patients without inhibitors.
- concizumab (NN7415) / Novo Nordisk
[VIRTUAL] ROTEM ASSAY CONDITIONS SENSITIVE TO CONCIZUMAB () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_17;
Results from the combined main and extension parts of explorer5 support the clinical proof of concept established in the main part of the trial and provided details of the longer‐term efficacy and safety of subcutaneous prophylactic treatment with concizumab in HA patients without inhibitors. ROTEM analysis of HA‐like blood using diluted r ex‐tem® reagent resulted in concentration‐dependent responses between 200–4000 ng/mL concizumab, a range corresponding to the target exposure in the ongoing phase 3 clinical trials.
- | Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk
Journal: Investigational drugs to treat hemophilia. (Pubmed Central) - Nov 27, 2020
The anti-tissue factor pathway inhibitor antibody concizumab is the most innovative and interesting agent among non-clotting factor products. If the results of ongoing trials confirm the preliminary positive results, these promising agents will provide further improvements in the management and quality of life of patients with hemophilia.
- concizumab (NN7415) / Novo Nordisk
[VIRTUAL] A Population Pharmacokinetic Model for Concizumab Based on Phase 1 and Phase 2 Trial Data (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_3499;
Structure of the final concizumab PK model for SC and IV dosing with target-mediated drug disposition via the endothelial TFPI. CL, clearance; doseiv, intravenous dose; dosesc, subcutaneous dose; IV, intravenous; ka, absorption rate constant; kcom, elimination rate constant of the concizumab-TFPI complex; kon and koff, rate constants for binding of concizumab to the endothelial TFPI; ktr, rate constant from the transit compartment; Q, inter-compartmental clearance; Rtot, amount of endothelial TFPI available for concizumab binding; SC, subcutaneous; TFPI, tissue factor pathway inhibitor; V, volume.
- concizumab (NN7415) / Novo Nordisk
[VIRTUAL] Safety and Longer-Term Efficacy of Concizumab Prophylaxis in Patients with Hemophilia a or b with Inhibitors: Results from the Extension Part of the Phase 2 explorer4 Trial (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_3494;
P2
Elevated prothrombin fragment 1+2 and D-dimer levels were observed in some patients treated with concizumab. Conclusions Results from the combined main and extension parts of the phase 2 explorer4 trial were in line with the clinical proof of concept established in the main part of the trial and provided further details of the safety and longer-term efficacy of subcutaneous prophylactic treatment with concizumab for at least 76 weeks in patients with HAwI and HBwI.
- concizumab (NN7415) / Novo Nordisk
[VIRTUAL] Risk Mitigation Strategy for Concizumab Clinical Trials after Pause Due to Non-Fatal Thrombotic Events (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_2259;
P3
Based on these analyses, risk mitigation plans were developed, including guidelines for the concomitant use of hemostatic agents in the management of bleeding episodes while on concizumab prophylaxis and updates to the concizumab dosing regimen. Conclusion Novo Nordisk has assessed all available data and defined risk mitigation strategies and changes to the explorer trial protocols.
- concizumab (NN7415) / Novo Nordisk
[VIRTUAL] The in Vitro Effect on Thrombin Generation of Adding rFVIII or rFIX to Hemophilia a or b Plasma in the Absence or Presence of Concizumab (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_2240;
P2
The combined effects of rFVIII/rFIX with concizumab were mainly additive with an up to 20% additional effect caused by drug-drug interaction with rFVIII and a 10% reduction with rFIX. No signs of exaggerated thrombin generation were observed by combining concizumab with rFVIII/rFIX.
- ||| Alhemo (concizumab) / Novo Nordisk
Trial completion date, Trial primary completion date: explorer8: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors (clinicaltrials.gov) - Oct 26, 2020
P3, N=158, Recruiting, Sponsor: Novo Nordisk A/S
No signs of exaggerated thrombin generation were observed by combining concizumab with rFVIII/rFIX. Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Nov 2021 --> May 2022
- |||| Alhemo (concizumab) / Novo Nordisk
Enrollment open, Trial primary completion date: explorer8: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors (clinicaltrials.gov) - Oct 1, 2020
P3, N=158, Recruiting, Sponsor: Novo Nordisk A/S
Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Nov 2021 --> May 2022 Suspended --> Recruiting | Trial primary completion date: Oct 2020 --> Nov 2021
- |||| Alhemo (concizumab) / Novo Nordisk
Enrollment open: explorer7: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors (clinicaltrials.gov) - Oct 1, 2020
P3, N=136, Recruiting, Sponsor: Novo Nordisk A/S
Suspended --> Recruiting | Trial primary completion date: Oct 2020 --> Nov 2021 Active, not recruiting --> Recruiting
- | Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
Review, Journal: Paradigm shift for the treatment of hereditary haemophilia: Towards precision medicine. (Pubmed Central) - Sep 25, 2020
As individual outcomes will be improved and the risk of adverse events minimized, non-factor products will come into wider use within the haemophilia community, and patients will hopefully have no more risks of breakthrough bleeds. The risks of a normal life for a "former haemophilia patient" is likely to change the treatment landscape and the structure of haemophilia Centers.
- |||| Alhemo (concizumab) / Novo Nordisk
Enrollment closed, Trial completion date, Trial primary completion date: explorer7: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors (clinicaltrials.gov) - Aug 23, 2020
P3, N=136, Active, not recruiting, Sponsor: Novo Nordisk A/S
The risks of a normal life for a "former haemophilia patient" is likely to change the treatment landscape and the structure of haemophilia Centers. Suspended --> Active, not recruiting | Trial completion date: Mar 2023 --> Jun 2024 | Trial primary completion date: Oct 2020 --> Nov 2021
- Alhemo (concizumab) / Novo Nordisk
Trial completion date: explorer8: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors (clinicaltrials.gov) - Jul 9, 2020
P3, N=150, Suspended, Sponsor: Novo Nordisk A/S
Suspended --> Active, not recruiting | Trial completion date: Mar 2023 --> Jun 2024 | Trial primary completion date: Oct 2020 --> Nov 2021 Trial completion date: Mar 2023 --> Jun 2024
- || Alhemo (concizumab) / Novo Nordisk
Trial completion: explorer (clinicaltrials.gov) - Jun 11, 2020
P2, N=36, Completed, Sponsor: Novo Nordisk A/S
Trial completion date: Mar 2023 --> Jun 2024 Suspended --> Completed
- | Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
Review, Journal: Hemophilia in a Changing Treatment Landscape. (Pubmed Central) - May 27, 2020
These include the development of extended half-life factors that require less frequent infusions and the development of various novel agents that can be given subcutaneously and infrequently, including FVIII-mimetic antibody and downregulators of natural anticoagulants. Finally, gene therapy is set to offer patients a possibility for a cure.
- concizumab (NN7415) / Novo Nordisk
[VIRTUAL] In vitro Effect of Concizumab on Protein C Activation and Antithrombin Activity (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_801;
Concizumab did not affect protein C activation or antithrombin activity in an in vitro set-up, consistent with its specificity for TFPI. The data suggest that the function of these downstream major coagulation inhibitors may be maintained in patients with hemophilia receiving concizumab prophylaxis.
- 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.
- | concizumab (NN7415) / Novo Nordisk
Journal: Concizumab promotes haemostasis via a tissue factor-factor VIIa-dependent mechanism supporting prophylactic treatment of haemophilia: Results from a rabbit haemophilia bleeding model. (Pubmed Central) - Apr 14, 2020
Furthermore, concizumab did not affect FVIII or FIX activity measurements using either an OSC or CS assay. No abstract available
- | concizumab (NN7415) / Novo Nordisk
Journal: Administration of rFVIIa to concizumab-dosed monkeys is safe and concizumab does not affect the potency of rFVIIa in hemophilic rabbits. (Pubmed Central) - Apr 10, 2020
Concizumab did not affect the potency or safety of rFVIIa in vivo. These results support a clinical evaluation of rFVIIa at standard dose (90 μg/kg) to treat break-through bleeds in concizumab clinical trials.
- ||| Alhemo (concizumab) / Novo Nordisk
Trial suspension: explorer (clinicaltrials.gov) - Mar 31, 2020
P2, N=36, Suspended, Sponsor: Novo Nordisk A/S
These results support a clinical evaluation of rFVIIa at standard dose (90 μg/kg) to treat break-through bleeds in concizumab clinical trials. Active, not recruiting --> Suspended
- ||||||| Alhemo (concizumab) / Novo Nordisk
Trial suspension: explorer7: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors (clinicaltrials.gov) - Mar 27, 2020
P3, N=152, Suspended, Sponsor: Novo Nordisk A/S
Active, not recruiting --> Suspended Recruiting --> Suspended
- ||||||| Alhemo (concizumab) / Novo Nordisk
Trial suspension: explorer8: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors (clinicaltrials.gov) - Mar 27, 2020
P3, N=150, Suspended, Sponsor: Novo Nordisk A/S
Recruiting --> Suspended Recruiting --> Suspended
- || concizumab (NN7415) / Novo Nordisk
P2 data, Journal: Subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors: Phase 2 trial results. (Pubmed Central) - Mar 19, 2020
P2
Three patients had (very-low to medium-titer) ADA-positive tests in each trial, with no observed clinical effect. These results support further development of concizumab as a daily prophylactic treatment in all hemophilia patients.
- |||| concizumab (NN7415) / Novo Nordisk
#PRESS Novo Nordisk pauses trials investigating concizumab (anti-TFPI mAB) in haemophilia A and B with or without inhibitors (Twitter) - Mar 16, 2020
- |||||||| Alhemo (concizumab) / Novo Nordisk
New P3 trial: Research study to look at how well the drug concizumab works in your body if you have haemophilia (EUDRACT) - Feb 27, 2020
P3, N=80, , Sponsor: Novo Nordisk A/S
- || Alhemo (concizumab) / Novo Nordisk
Trial completion: explorer (clinicaltrials.gov) - Feb 10, 2020
P2, N=26, Completed, Sponsor: Novo Nordisk A/S
These results support further development of concizumab as a daily prophylactic treatment in all hemophilia patients. Active, not recruiting --> Completed
- || concizumab (NN7415) / Novo Nordisk
PK/PD data, Journal: A systems pharmacokinetic/pharmacodynamic model for concizumab to explore the potential of anti-TFPI recycling antibodies. (Pubmed Central) - Feb 7, 2020
The systems PK/PD model predicted that an anti-TFPI recycling antibody with a 100-fold higher mTFPI/sTFPI dissociation constant in endosomes than concizumab can extend sTFPI suppression from 12 days to 1 month. Thus, the systems PK/PD model provides a quantitative platform for guiding the engineering and translational development of anti-TFPI recycling antibodies.
- concizumab (NN7415) / Novo Nordisk
Successful perioperative hemostasis use of rFVIIa in major orthopedic surgery in a severe hemophilia B patient with inhibitors on concizumab prophylaxis () - Feb 4, 2020 - Abstract #EAHAD2020EAHAD_447;
The low‐dose rFVIIa regimen and concizumab was safe with no occurrence of thrombosis and was sufficient to prevent bleeding complications. Modified ROTEM was useful for the individualization of rFVIIa therapy
- concizumab (NN7415) / Novo Nordisk
Phase 2 concizumab population pharmacokinetic and exposure‐response analyses: Application to phase 3 dose selection () - Feb 4, 2020 - Abstract #EAHAD2020EAHAD_443;
P2
Modified ROTEM was useful for the individualization of rFVIIa therapy PK and exposure‐response analyses support the concizumab dosing regimen of a loading dose of 1 mg/kg, followed by a daily prophylactic dose of 0.25 mg/kg in the phase 3 explorer7 (HAwI/HBwI) and explorer8 (HA/HB) trials.
- concizumab (NN7415) / Novo Nordisk
Successful laser refractive eye surgery during treatment with concizumab in a patient with severe haemophilia A with an inhibitor () - Feb 4, 2020 - Abstract #EAHAD2020EAHAD_303;
As the role of non‐factor replacement therapies in haemophilia increases, greater clinical experience is required to determine optimal peri‐procedural management of haemostasis in this context. However, this case indicates that laser eye surgery may be offered to this patient group and demonstrates the efficacy of single agent concizumab in minor surgery in a patient with a severe bleeding phenotype.
- || concizumab (NN7415) / Novo Nordisk
Clinical, P1 data, PK/PD data, Journal: Safety, pharmacokinetics and pharmacodynamics of concizumab in people with hemophilia A: a phase 1b, randomized trial. (Pubmed Central) - Nov 24, 2019
P1
However, this case indicates that laser eye surgery may be offered to this patient group and demonstrates the efficacy of single agent concizumab in minor surgery in a patient with a severe bleeding phenotype. explorer 3 data support further clinical development of concizumab for use in people with hemophilia, with or without inhibitors.
- | Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
Review, Journal: Advances in the Treatment of Hemophilia: Implications for Laboratory Testing. (Pubmed Central) - Nov 23, 2019
Although no definitive conclusions can presently be drawn, chromogenic assays are probably more suitable than one-stage clotting. (c) Novel drugs not based on coagulation factors such as emicizumab, fitusiran, or concizumab that are entering the market do require alternative methods that are not yet well established.
- |||| Alhemo (concizumab) / Novo Nordisk
Enrollment open: explorer8: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors (clinicaltrials.gov) - Nov 18, 2019
P3, N=150, Recruiting, Sponsor: Novo Nordisk A/S
(c) Novel drugs not based on coagulation factors such as emicizumab, fitusiran, or concizumab that are entering the market do require alternative methods that are not yet well established. Not yet recruiting --> Recruiting
- concizumab (NN7415) / Novo Nordisk
Thrombin Generation Assay in Plasma from Hemophilia a Patients with or without Inhibitors on Concizumab Prophylaxis: Spiking with rFVIIa or aPCC (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_5353;
P2
Thus, the bypassing agents function as expected in plasma containing concizumab . The effects of concizumab and rFVIIa or aPCC were mainly additive .
- concizumab (NN7415) / Novo Nordisk
Concizumab Subcutaneous Prophylaxis Improves Health-Related Quality-of-Life Measures in Patients with Congenital Hemophilia with Inhibitors: Phase 2 Trial Results (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_3577;
P2
The larger reduction in ABR observed with concizumab subcutaneous prophylaxis may have contributed to the larger improvement in HRQoL relative to the rFVIIa on-demand treatment arm . The potential beneficial effect of concizumab prophylaxis on HRQoL in all hemophilia patients will be investigated further in the phase 3 trials.
- concizumab (NN7415) / Novo Nordisk
Efficacy and Safety of Subcutaneous Prophylaxis with Concizumab in Patients with Severe Hemophilia a without Inhibitors: Results from the Phase 2 explorer5 Trial (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_3575;
P2
Conclusions In the phase 2 explorer5 trial, concizumab was efficacious and safe as a subcutaneous prophylactic treatment for HA patients without inhibitors . The phase 2 trial results, which include the explorer4 trial in HA with inhibitors and hemophilia B with inhibitors, support further development of concizumab as a prophylactic treatment for all hemophilia patients and have guided selection of the phase 3 dosing regimen.
- concizumab (NN7415) / Novo Nordisk
Efficacy and Safety of Subcutaneous Prophylaxis with Concizumab in Patients with Hemophilia a or B with Inhibitors: Results from explorer4, a Phase 2, Randomized, Open-Label, Controlled Trial (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_1947;
P2
There was no difference in safety and efficacy across hemophilia subtypes, including with the concomitant use of concizumab and the bypassing agent rFVIIa . The phase 2 trial results, which include the explorer5 trial in HA without inhibitors, support further development of concizumab as a prophylactic treatment for all hemophilia patients and have guided selection of the phase 3 dosing regimen.
- | Alhemo (concizumab) / Novo Nordisk
Enrollment open: explorer7: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors (clinicaltrials.gov) - Oct 24, 2019
P3, N=152, Recruiting, Sponsor: Novo Nordisk A/S
The phase 2 trial results, which include the explorer5 trial in HA without inhibitors, support further development of concizumab as a prophylactic treatment for all hemophilia patients and have guided selection of the phase 3 dosing regimen. Not yet recruiting --> Recruiting
- | Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
Clinical, Journal: New therapies using non-factor products for patients with hemophilia and inhibitors. (Pubmed Central) - Oct 8, 2019
Moreover, reliable techniques to monitor hemostatic function in patients received non-factor products with concomitant BPA or FVIII/FIX therapies require further assessment. These novel therapeutic agents have promising hemostatic properties, although wider experience in hemophilia centers is warranted to establish appropriate therapeutic strategies.
- | Alhemo (concizumab) / Novo Nordisk
New P3 trial: explorer7: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors (clinicaltrials.gov) - Sep 9, 2019
P3, N=152, Not yet recruiting, Sponsor: Novo Nordisk A/S
These novel therapeutic agents have promising hemostatic properties, although wider experience in hemophilia centers is warranted to establish appropriate therapeutic strategies. .
- | Alhemo (concizumab) / Novo Nordisk
New P3 trial: explorer8: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors (clinicaltrials.gov) - Sep 9, 2019
P3, N=150, Not yet recruiting, Sponsor: Novo Nordisk A/S
- | concizumab (NN7415) / Novo Nordisk
Biomarker, Clinical, P1 data, PK/PD data, Journal: Concizumab restores thrombin generation potential in patients with haemophilia: Pharmacokinetic/pharmacodynamic modelling results of concizumab phase 1/1b data. (Pubmed Central) - Apr 30, 2019
. Concizumab phase 2 trials will target an exposure ≥100 ng/mL, with a once-daily regimen.
- | Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
Clinical, Review, Journal: Attempting to remedy sub-optimal medication adherence in haemophilia: The rationale for repeated ultrasound visualisations of the patient's joint status. (Pubmed Central) - Apr 28, 2019
Furthermore, in patients with haemophilia undergoing prophylaxis with an extended half-life product for a ≈ 2.8 year period, a significant continued improvement in joint health is detected at the physical examination. This provides the rationale for studies on repeated ultrasound examinations of joint status to attempt to remedy sub-optimal medication adherence and help identify which approach is most suited on which occasion and for which patient.
- | concizumab (NN7415) / Novo Nordisk
Journal: Inhibition of Tissue Factor Pathway Inhibitor (TFPI) as a Treatment for Haemophilia: Rationale with Focus on Concizumab. (Pubmed Central) - Mar 29, 2019
Pharmacokinetic parameters were influenced by binding to the target (TFPI), demonstrating target mediated drug disposition. A trend towards decreasing bleeding tendency was observed and this preventative effect is being studied in Phase 2 studies with additional data gathered to improve our understanding of the therapeutic window and potential for thrombosis.