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10 Diseases |  |
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6 Trials |  |
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- Nuwiq (simoctocog alfa) / Octapharma
Unravelling the challenges of haemophilia A: Efficacy, immunogenicity and inhibitor management with Nuwiq® (simoctocog alfa) (Atlantic Room EAHAD 2020, The Hague) - Jan 27, 2020 - Abstract #EAHAD2020EAHAD_217;
Increased understanding of the implications of FVIII deficiency and different therapeutical approaches may provide a new angle on HA care, and are critical for us to unravel the full complexity of the challenges of HA. This satellite symposium is Organised and funded by Octapharma
- | Nuwiq (simoctocog alfa) / Octapharma
Journal: Estimation of Nuwiq (simoctocog alfa) activity using one-stage and chromogenic assays-Results from an international comparative field study. (Pubmed Central) - Dec 23, 2019
This satellite symposium is Organised and funded by Octapharma Both OSAs and CSAs are suitable for the measurement of FVIII:C of Nuwiq in routine laboratory practice, without the need for a product-specific reference standard.
- || 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.
- Nuwiq (simoctocog alfa) / Octapharma
A snapshot of a prospective, noninterventional study to evaluate routine practice prophylactic treatment schedules - NIS-Previq (Industry Exhibition/Foyer) - Dec 17, 2019 - Abstract #GTH2020GTH_161;
The snapshot on the study data so far confirm the good tolerability and efficacy of the concentrates studied. Such a study allows to further evaluate the real-life application of prescribed prophylactic schedules.
- Nuwiq (simoctocog alfa) / Octapharma
Nuwiq® (simoctocog alfa) now and beyond (Focke) - Dec 17, 2019 - Abstract #GTH2020GTH_134;
- || Trial initiation date: MOTIVATE: Treatment of Hemophilia A Patients With FVIII Inhibitors (clinicaltrials.gov) - Dec 12, 2019
P=N/A, N=120, Not yet recruiting, Sponsor: Emory University
Such a study allows to further evaluate the real-life application of prescribed prophylactic schedules. Initiation date: Nov 2019 --> Feb 2020
- || Nuwiq (simoctocog alfa) / Octapharma
Trial completion date, Trial primary completion date: GENA-99: Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ (clinicaltrials.gov) - Dec 5, 2019
P=N/A, N=200, Recruiting, Sponsor: Octapharma
Initiation date: Nov 2019 --> Feb 2020 Trial completion date: Dec 2019 --> Jul 2020 | Trial primary completion date: Dec 2019 --> Jul 2020
- Nuwiq (simoctocog alfa) / Octapharma
Inhibitor Development with Simoctocog Alfa in Previously Untreated Patients with Severe Haemophilia a: Final Results of the Nuprotect Study (Tangerine 1 (WF1), Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_6568;
References Liesner R, et al . Haemophilia 2018; 24: 211-20.
- 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.
- | Nuwiq (simoctocog alfa) / Octapharma
Trial completion date: NuProtect: Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients (clinicaltrials.gov) - Jul 29, 2019
P3, N=110, Active, not recruiting, Sponsor: Octapharma
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 completion date: Dec 2019 --> Mar 2020
- | Hemlibra (emicizumab-kxwh) / Roche, Nuwiq (simoctocog alfa) / Octapharma
New P3 trial: Emicizumab PUPs and Nuwiq ITI Study (clinicaltrials.gov) - Jul 23, 2019
P3, N=60, Not yet recruiting, Sponsor: Emory University
- | New trial: MOTIVATE: Treatment of Hemophilia A Patients With FVIII Inhibitors (clinicaltrials.gov) - Jul 16, 2019
P, N=120, Not yet recruiting, Sponsor: Emory University
- | Nuwiq (simoctocog alfa) / Octapharma
Clinical, Review, Journal: Efficacy and safety of simoctocog alfa (Nuwiq®) in patients with severe hemophilia A: a review of clinical trial data from the GENA program. (Pubmed Central) - Jul 3, 2019
No FVIII inhibitors were detected in PTPs after treatment with 43,267 injections and >80 million IU of Nuwiq®. Interim data for 66 PUPs with ⩾20 exposure days to Nuwiq® in NuProtect demonstrated a low cumulative high-titer inhibitor rate of 12.8% [actual incidence 12.1% (8/66)] and convincing efficacy and safety.
- | Nuwiq (simoctocog alfa) / Octapharma
Clinical, Journal: Continuous infusion of simoctocog alfa in haemophilia A patients undergoing surgeries. (Pubmed Central) - Apr 30, 2019
Continuous infusion with simoctocog alfa was found to achieve good/excellent haemostatic efficacy in all procedures. No adverse events occurred and no inhibitors developed.
- ||||| Nuwiq (simoctocog alfa) / Octapharma
Trial completion, Enrollment change: NuProtect: Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII (clinicaltrials.gov) - Feb 28, 2019
P3, N=48, Completed, Sponsor: Octapharma
No adverse events occurred and no inhibitors developed. Active, not recruiting --> Completed | N=100 --> 48
- | 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 21, 2018
P4, N=50, , Sponsor: Erasmus University Medical Center
- || Nuwiq (simoctocog alfa) / Octapharma
Trial completion date, Trial primary completion date: GENA-99: Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ (clinicaltrials.gov) - Dec 6, 2018
P=N/A, N=200, Recruiting, Sponsor: Octapharma
Active, not recruiting --> Completed | N=100 --> 48 Trial completion date: Jun 2019 --> Dec 2019 | Trial primary completion date: Jun 2019 --> Dec 2019
- | Nuwiq (simoctocog alfa) / Octapharma
Trial completion date: NuProtect: Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients (clinicaltrials.gov) - Nov 20, 2018
P3, N=110, Active, not recruiting, Sponsor: Octapharma
Trial completion date: Jun 2019 --> Dec 2019 | Trial primary completion date: Jun 2019 --> Dec 2019 Trial completion date: Dec 2018 --> Dec 2019
- ||||| Nuwiq (simoctocog alfa) / Octapharma
Trial completion: Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A (clinicaltrials.gov) - Oct 9, 2018
P3b, N=58, Completed, Sponsor: Octapharma
Trial completion date: Dec 2018 --> Dec 2019 Active, not recruiting --> Completed
- | Nuwiq (simoctocog alfa) / Octapharma
Clinical, Journal: Immunogenicity, efficacy and safety of Nuwiq(®) (human-cl rhFVIII) in previously untreated patients with severe haemophilia A-Interim results from the NuProtect Study. (Pubmed Central) - Sep 7, 2018
Active, not recruiting --> Completed These interim data show a cumulative incidence of 12.8% for HT inhibitors and convincing efficacy and tolerability in PUPs treated with Nuwiq .
- | Nuwiq (simoctocog alfa) / Octapharma
Trial completion date: GENA-99: Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ (clinicaltrials.gov) - Aug 22, 2018
P=N/A, N=200, Recruiting, Sponsor: Octapharma
These interim data show a cumulative incidence of 12.8% for HT inhibitors and convincing efficacy and tolerability in PUPs treated with Nuwiq . Trial completion date: Mar 2020 --> Jun 2019
- | Nuwiq (simoctocog alfa) / Octapharma
Clinical, Journal: Efficacy and safety of Nuwiq(®) (human-cl rhFVIII) in patients with severe haemophilia A undergoing surgical procedures. (Pubmed Central) - Jul 27, 2018
Trial completion date: Mar 2020 --> Jun 2019 The results of this pooled analysis show that Nuwiq was efficacious in maintaining haemostasis during and after major and minor surgical procedures in PTPs with severe haemophilia A.
- ||| Wilate (human factor VIII/von Willebrand factor) / Octapharma, Nuwiq (simoctocog alfa) / Octapharma
Enrollment open: PREVAIL: Immune Tolerance Induction in Haemophilia A Patients Using Wilate or Nuwiq (clinicaltrials.gov) - Jul 23, 2018
P=N/A, N=80, Recruiting, Sponsor: Octapharma
The results of this pooled analysis show that Nuwiq was efficacious in maintaining haemostasis during and after major and minor surgical procedures in PTPs with severe haemophilia A. Not yet recruiting --> Recruiting
- || Wilate (human factor VIII/von Willebrand factor) / Octapharma, Nuwiq (simoctocog alfa) / Octapharma
Trial completion date, Trial primary completion date: PREVAIL: Immune Tolerance Induction in Haemophilia A Patients Using Wilate or Nuwiq (clinicaltrials.gov) - Jun 7, 2018
P=N/A, N=80, Not yet recruiting, Sponsor: Octapharma
Not yet recruiting --> Recruiting Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2026 --> Dec 2027
- ||||| Nuwiq (simoctocog alfa) / Octapharma
Enrollment closed, Trial completion date, Trial primary completion date: NuProtect: Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII (clinicaltrials.gov) - Apr 18, 2018
P3, N=100, Active, not recruiting, Sponsor: Octapharma
Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2026 --> Dec 2027 Recruiting --> Active, not recruiting | Trial completion date: Apr 2018 --> Dec 2018 | Trial primary completion date: Apr 2018 --> Dec 2018
- || Wilate (human factor VIII/von Willebrand factor) / Octapharma, Nuwiq (simoctocog alfa) / Octapharma
Trial initiation date: PREVAIL: Immune Tolerance Induction in Haemophilia A Patients Using Wilate or Nuwiq (clinicaltrials.gov) - Jan 30, 2018
P=N/A, N=80, Not yet recruiting, Sponsor: Octapharma
Recruiting --> Active, not recruiting | Trial completion date: Apr 2018 --> Dec 2018 | Trial primary completion date: Apr 2018 --> Dec 2018 Initiation date: Dec 2017 --> Mar 2018
- ||||| Nuwiq (simoctocog alfa) / Octapharma
Enrollment closed: Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A (clinicaltrials.gov) - Jan 30, 2018
P3b, N=55, Active, not recruiting, Sponsor: Octapharma
Initiation date: Dec 2017 --> Mar 2018 Recruiting --> Active, not recruiting
- ||| Wilate (human factor VIII/von Willebrand factor) / Octapharma, Nuwiq (simoctocog alfa) / Octapharma
New trial: PREVAIL: Immune Tolerance Induction in Haemophilia A Patients Using Wilate or Nuwiq (clinicaltrials.gov) - Nov 17, 2017
P=N/A, N=80, Not yet recruiting, Sponsor: Octapharma
- |||| Nuwiq (simoctocog alfa) / Octapharma
Trial primary completion date: Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A (clinicaltrials.gov) - Jun 29, 2017
P3b, N=55, Recruiting, Sponsor: Octapharma
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2017 --> Sep 2018
- ||| Nuwiq (simoctocog alfa) / Octapharma
New trial: GENA-99: Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ (clinicaltrials.gov) - Nov 13, 2016
P=N/A, N=200, Recruiting, Sponsor: Octapharma
- || Nuwiq (simoctocog alfa) / Octapharma
Phase classification: Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A (clinicaltrials.gov) - Oct 20, 2016
P3b, N=55, Recruiting, Sponsor: Octapharma
Trial primary completion date: Dec 2017 --> Sep 2018 Phase classification: P3 --> P3b
- ||||| Nuwiq (simoctocog alfa) / Octapharma
Enrollment closed: NuProtect: Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients (clinicaltrials.gov) - Oct 6, 2016
P3, N=110, Active, not recruiting, Sponsor: Octapharma
Phase classification: P3 --> P3b Recruiting --> Active, not recruiting
- |||| Nuwiq (simoctocog alfa) / Octapharma
Trial primary completion date: Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A (clinicaltrials.gov) - May 4, 2016
P3, N=55, Recruiting, Sponsor: Octapharma
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2016 --> Dec 2017
- |||| Nuwiq (simoctocog alfa) / Octapharma
Trial primary completion date: NuProtect: Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII (clinicaltrials.gov) - Oct 22, 2015
P3, N=100, Recruiting, Sponsor: Octapharma
Trial primary completion date: Dec 2016 --> Dec 2017 Trial primary completion date: Apr 2016 --> Apr 2018
- ||| Enrollment open: ATHN 2: Factor Switching Study (clinicaltrials.gov) - Oct 22, 2015
P=N/A, N=600, Recruiting, Sponsor: American Thrombosis and Hemostasis Network
Trial primary completion date: Apr 2016 --> Apr 2018 Not yet recruiting --> Recruiting
- ||| New trial: ATHN 2: Factor Switching Study (clinicaltrials.gov) - Sep 14, 2015
P=N/A, N=600, Not yet recruiting, Sponsor: American Thrombosis and Hemostasis Network
- |||||| Nuwiq (simoctocog alfa) / Octapharma
Enrollment open: Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A (clinicaltrials.gov) - Apr 22, 2015
P3, N=55, Recruiting, Sponsor: Octapharma
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||||| Nuwiq (simoctocog alfa) / Octapharma
Trial completion: NuPreviq: Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A (clinicaltrials.gov) - Jan 22, 2015
P3, N=66, Completed, Sponsor: Octapharma
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- |||||||||| Nuwiq (simoctocog alfa) / Octapharma
New P3 trial: Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A (clinicaltrials.gov) - Oct 10, 2014
P3, N=55, Not yet recruiting, Sponsor: Octapharma
- ||||| Nuwiq (simoctocog alfa) / Octapharma
Enrollment closed, Enrollment change: NuPreviq: Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A (clinicaltrials.gov) - Jul 30, 2014
P3, N=66, Active, not recruiting, Sponsor: Octapharma
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | N=55 --> 66
- |||| Nuwiq (simoctocog alfa) / Octapharma
Trial primary completion date: NuProtect: Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII (clinicaltrials.gov) - May 18, 2014
P3, N=100, Recruiting, Sponsor: Octapharma
Recruiting --> Active, not recruiting | N=55 --> 66 Trial primary completion date: Jan 2016 --> Apr 2016
- ||||| Nuwiq (simoctocog alfa) / Octapharma
Trial initiation date: NuProtect: Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII (clinicaltrials.gov) - May 18, 2014
P3, N=100, Recruiting, Sponsor: Octapharma
Trial primary completion date: Jan 2016 --> Apr 2016 Initiation date: Jan 2014 --> Apr 2014
- |||||| Nuwiq (simoctocog alfa) / Octapharma
Enrollment open: NuProtect: Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII (clinicaltrials.gov) - May 18, 2014
P3, N=100, Recruiting, Sponsor: Octapharma
Initiation date: Jan 2014 --> Apr 2014 Not yet recruiting --> Recruiting
- ||||| Nuwiq (simoctocog alfa) / Octapharma
Trial initiation date: NuProtect: Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients (clinicaltrials.gov) - Apr 14, 2014
P3, N=100, Ongoing, Sponsor: OCTAPHARMA AG
Not yet recruiting --> Recruiting Initiation date: Feb 2013 --> Feb 2013
- |||||||||| Nuwiq (simoctocog alfa) / Octapharma
New P3 trial: NuProtect: Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII (clinicaltrials.gov) - Nov 21, 2013
P3, N=100, Not yet recruiting, Sponsor: Octapharma
- |||||||||| Nuwiq (simoctocog alfa) / Octapharma
New P3 trial: NuPreviq: Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A (clinicaltrials.gov) - May 27, 2013
P3, N=55, Recruiting, Sponsor: Octapharma
- |||||||||| Nuwiq (simoctocog alfa) / Octapharma
New P3 trial: NuProtect: Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients (clinicaltrials.gov) - Oct 21, 2012
P3, N=100, Ongoing, Sponsor: OCTAPHARMA AG
- Nuwiq (simoctocog alfa) / Octapharma
Enrollment change: Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs) (clinicaltrials.gov) - Oct 1, 2012
P3, N=3, Completed, Sponsor: Octapharma
Initiation date: Feb 2013 --> Feb 2013 N=20 --> 3
- Nuwiq (simoctocog alfa) / Octapharma
Trial completion: Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs) (clinicaltrials.gov) - Oct 1, 2012
P3, N=3, Completed, Sponsor: Octapharma
N=20 --> 3 Enrolling by invitation --> Completed
- | Nuwiq (simoctocog alfa) / Octapharma
Trial completion: Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A (clinicaltrials.gov) - Oct 1, 2012
P2, N=22, Completed, Sponsor: Octapharma
Enrolling by invitation --> Completed Active, not recruiting --> Completed