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16 Products |  |
56 Diseases | | 16 Products |
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40 Trials |  |
926 News |  |
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- | 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
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.
- || Gammanorm (human immune globulin subcutaneous) / Octapharma
Clinical, Journal: Octanorm [cutaquig®], a new immunoglobulin (human) subcutaneous 16.5% solution for injection (165 mg/mL) - Biochemical characterization, pathogen safety, and stability. (Pubmed Central) - Dec 23, 2019
Substantial prion depletion during the manufacturing process has also been demonstrated. Compared with other commercially available subcutaneous immunoglobulin (SCIG) 20% products, Octanorm 16.5% shows a lower viscosity, which is a valuable feature that allows for a more comfortable infusion experience.
- || 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.
- Fibryga (fibrinogen concentrate (human)) / Octapharma
A phase III study to assess the efficacy and safety of fibrinogen concentrate for on-demand treatment of acute bleeding and surgical prophylaxis in paediatric subjects with congenital fibrinogen deficiency (Borgward) - Dec 17, 2019 - Abstract #GTH2020GTH_216;
HFC treatment was efficacious for ondemand treatment of acute BEs and for surgical prophylaxis in paediatric patients with CFD. Furthermore, HFC treatment demonstrated a favourable safety profile in this study population.
- Wilate (human factor VIII/von Willebrand factor) / Octapharma
Clinical study to investigate the efficacy and safety of a Von Willebrand factor FVIII concentrate (VWF/FVIII) during prophylaxis in previously treated patients with Von Willebrand disease (VWD) (Industry Exhibition/Foyer) - Dec 17, 2019 - Abstract #GTH2020GTH_173;
Prophylactic treatment in other congenital bleeding disorders is widely accepted as the standard of care to prevent bleeding and preserve QoL in patients, but to date, no sufficient data addresses long term VWD prophylaxis. This study will provide data on the efficacy of prophylactic treatment in reducing the rate of bleeding and on the impact of prophylaxis on the QoL, joint status and severity of menstrual bleeds in VWD patients.
- 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;
- 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
- || 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
Part of the work was supported by a grant of Bayer Vital GmbH, 51368 Leverkusen, Germany 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
- Panzyga (human immune globulin intravenous 10% stabilised with glycine) / Octapharma
Enrollment open: Study to Evaluate the Efficacy and Safety of PANZYGA in Pediatric Patients With Chronic Immune Thrombocytopenia (ITP) (clinicaltrials.gov) - Nov 28, 2019
P4, N=20, Recruiting, Sponsor: Octapharma
Trial completion date: Dec 2019 --> Jul 2020 | Trial primary completion date: Dec 2019 --> Jul 2020 Not yet recruiting --> Recruiting
- || Privigen (human immune globulin intravenous 10%) / CSL Behring, Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion, Octagam (intravenous normal human immunoglobulin) / Octapharma
Trial completion, Trial completion date: Ig PRx in AECOPD: Pilot Study (clinicaltrials.gov) - Nov 27, 2019
P2, N=48, Completed, Sponsor: Ottawa Hospital Research Institute
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Nov 2019
- | ASP7317 / Octapharma, CHA Bio & Diostech, Astellas
Trial completion date, Trial primary completion date, Metastases: A Phase I/IIa, Open-Label, Single-Center, Prospective Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of Human Embryonic Stem Cell Derived Retinal Pigmented Epithelial(MA09-hRPE) Cells in Patients With Advanced Dry Age-related Macular Degeneration(AMD) (clinicaltrials.gov) - Nov 18, 2019
P1/2, N=12, Active, not recruiting, Sponsor: CHABiotech CO., Ltd
Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Nov 2019 Trial completion date: Apr 2016 --> Jun 2020 | Trial primary completion date: Feb 2016 --> Jun 2020
- ||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Trial completion: ProDERM: Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy) (clinicaltrials.gov) - Nov 18, 2019
P3, N=95, Completed, Sponsor: Octapharma
Trial completion date: Apr 2016 --> Jun 2020 | Trial primary completion date: Feb 2016 --> Jun 2020 Active, not recruiting --> Completed
- | Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
Enrollment change, Trial withdrawal: ATTEND: Autologous Transplant To End NMO Spectrum Disorder (clinicaltrials.gov) - Nov 8, 2019
P2/3, N=0, Withdrawn, Sponsor: Northwestern University
Active, not recruiting --> Completed N=50 --> 0 | Recruiting --> Withdrawn
- 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.
- || Panzyga (human immune globulin intravenous 10% stabilised with glycine) / Octapharma
New P2 trial: IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies (clinicaltrials.gov) - Nov 5, 2019
P2, N=20, Not yet recruiting, Sponsor: Lawrence Zeidman
- |||||| Wilate (human factor VIII/von Willebrand factor) / Octapharma
New trial: Von Willebrand Factor in Pregnancy (VIP) Study (clinicaltrials.gov) - Nov 5, 2019
P, N=110, Active, not recruiting, Sponsor: Bloodworks
- || ASP7317 / Octapharma, CHA Bio & Diostech, Astellas
Trial completion, Trial completion date, Trial primary completion date: Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Stargardt Macular Dystrophy Patients (clinicaltrials.gov) - Nov 3, 2019
P1/2, N=13, Completed, Sponsor: Astellas Institute for Regenerative Medicine
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. Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Jun 2019 | Trial primary completion date: Dec 2019 --> Jun 2019
- || ASP7317 / Octapharma, CHA Bio & Diostech, Astellas
Trial completion, Trial completion date, Trial primary completion date, Metastases: Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Patients With AMD (clinicaltrials.gov) - Oct 31, 2019
P1/2, N=11, Completed, Sponsor: Astellas Institute for Regenerative Medicine
Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Jun 2019 | Trial primary completion date: Dec 2019 --> Jun 2019 Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Jul 2019 | Trial primary completion date: Dec 2019 --> Jul 2019
- | Panzyga (human immune globulin intravenous 10% stabilised with glycine) / Octapharma
Clinical, P3 data, Journal: A randomized, multicentre phase III study of three different doses of intravenous immunoglobulin 10% in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ProCID trial): Study design and protocol. (Pubmed Central) - Oct 29, 2019
This randomised phase III study in patients with CIDP (ProCID trial) will compare the efficacy and safety of 3 different doses (0.5, 1.0, and 2.0 g/kg) of IVIg 10% (panzyga) administered every 3 weeks for 24 weeks...Safety, tolerability and quality of life will be assessed. The ProCID study will provide new information on the best maintenance dose of IVIg for patients with CIDP.
- | Fibryga (fibrinogen concentrate (human)) / Octapharma
Trial completion, Trial completion date, Surgery: FORMA-04: Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency (clinicaltrials.gov) - Oct 22, 2019
P3, N=6, Completed, Sponsor: Octapharma
The ProCID study will provide new information on the best maintenance dose of IVIg for patients with CIDP. Active, not recruiting --> Completed | Trial completion date: Dec 2020 --> Jun 2019
- | Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer, warfarin / Generic Mfg.
Clinical, Journal: Results of Octaplex for reversal of warfarin anticoagulation in patients with hip fracture. (Pubmed Central) - Oct 8, 2019
Octaplex is effective for rapidly reversing warfarin anticoagulation and reducing delays to hip fracture surgery. Further study comparing Octaplex to reversal using only vitamin K is required.
- | Panzyga (human immune globulin intravenous 10% stabilised with glycine) / Octapharma
Trial completion date: Study of Intravenous Immunoglobulin in Amnestic Mild Cognitive Impairment (clinicaltrials.gov) - Oct 8, 2019
P2, N=52, Active, not recruiting, Sponsor: Sutter Health
Further study comparing Octaplex to reversal using only vitamin K is required. Trial completion date: Dec 2018 --> Dec 2019
- | Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
New P2 trial, Surgery: FARES: Factor Replacement in Surgery (clinicaltrials.gov) - Oct 3, 2019
P2, N=120, Recruiting, Sponsor: University Health Network, Toronto
- | warfarin / Generic Mfg.
Clinical, Journal: Prothrombin Complex Concentrate for Warfarin-Associated Intracranial Bleeding in Neurosurgical Patients: A Single-Center Experience. (Pubmed Central) - Sep 28, 2019
Mortality was associated with lower Glasgow coma scale (GCS) score. The 4-PCC facilitates INR reversal and surgery in patients presenting with warfarin-associated coagulopathy and intracranial bleeding requiring urgent neurosurgical intervention.
- | Fibryga (fibrinogen concentrate (human)) / Octapharma
Clinical data, New trial, Real-world evidence, Real-world: Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data (clinicaltrials.gov) - Sep 27, 2019
P, N=264, Recruiting, Sponsor: Octapharma
- | Wilate (human factor VIII/von Willebrand factor) / Octapharma
New trial: Effectiveness and Tolerability of Eqwilate in Real-life Conditions (clinicaltrials.gov) - Sep 26, 2019
P, N=47, Not yet recruiting, Sponsor: Octapharma
- | Panzyga (human immune globulin intravenous 10% stabilised with glycine) / Octapharma
Trial completion: Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy (clinicaltrials.gov) - Sep 26, 2019
P3, N=142, Completed, Sponsor: Octapharma
The 4-PCC facilitates INR reversal and surgery in patients presenting with warfarin-associated coagulopathy and intracranial bleeding requiring urgent neurosurgical intervention. Active, not recruiting --> Completed
- | ASP7317 / Octapharma, CHA Bio & Diostech, Astellas
Review, Journal: Transplantation of human embryonic stem cell-derived retinal pigment epithelial cells (MA09-hRPE) in macular degeneration. (Pubmed Central) - Sep 5, 2019
Given that the technology is still at its infancy for human use, a new clinical regulatory path could aid in cell line validation through small cohort, adaptive clinical trials to accelerate product development toward commercialization. These strategic insights will be invaluable to help both academia and industry, collaboratively shorten the steep learning curve, and reduce large development expenditures spent on unnecessary lengthy clinical trials.
- | Panzyga (human immune globulin intravenous 10% stabilised with glycine) / Octapharma
Clinical, Journal: Intravenous immunoglobulin 10% in children with primary immunodeficiency diseases. (Pubmed Central) - Aug 30, 2019
These strategic insights will be invaluable to help both academia and industry, collaboratively shorten the steep learning curve, and reduce large development expenditures spent on unnecessary lengthy clinical trials. IVIG 10% is safe and effective for the treatment of predominantly antibody-deficient children.
- | Wilate (human factor VIII/von Willebrand factor) / Octapharma
New P3 trial: WIL-31: Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With VWD (clinicaltrials.gov) - Aug 11, 2019
P3, N=28, Enrolling by invitation, Sponsor: Octapharma
- | Fibryga (fibrinogen concentrate (human)) / Octapharma
Trial initiation date: Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency (clinicaltrials.gov) - Aug 6, 2019
P=N/A, N=25, Not yet recruiting, Sponsor: Octapharma
IVIG 10% is safe and effective for the treatment of predominantly antibody-deficient children. Initiation date: May 2019 --> Oct 2019
- | simoctocog alpha/von Willebrand Factor (OCTA101) / Octapharma
New P1/2 trial: Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A (clinicaltrials.gov) - Aug 5, 2019
P1/2, N=28, Recruiting, Sponsor: Octapharma
- | Fibryga (fibrinogen concentrate (human)) / Octapharma
Enrollment closed, Trial primary completion date, Surgery: FORMA-04: Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency (clinicaltrials.gov) - Jul 30, 2019
P3, N=6, Active, not recruiting, Sponsor: Octapharma
Initiation date: May 2019 --> Oct 2019 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2020 --> Jun 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) - Jul 29, 2019
P3, N=110, Active, not recruiting, Sponsor: Octapharma
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2020 --> Jun 2019 Trial completion date: Dec 2019 --> Mar 2020
- | Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
Trial initiation date: ATTEND: Autologous Transplant To End NMO Spectrum Disorder (clinicaltrials.gov) - Jul 25, 2019
P2/3, N=50, Recruiting, Sponsor: Northwestern University
Trial completion date: Dec 2019 --> Mar 2020 Initiation date: Jun 2019 --> Nov 2019
- | Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
Enrollment closed: CAST: Cardiac Safe Transplants for Systemic Sclerosis (clinicaltrials.gov) - Jul 25, 2019
P2/3, N=50, Active, not recruiting, Sponsor: Northwestern University
Initiation date: Jun 2019 --> Nov 2019 Recruiting --> Active, not recruiting
- | Gammanorm (human immune globulin subcutaneous) / Octapharma
Clinical, Journal, HEOR: Efficacy, safety and quality of life in patients receiving subcutaneous IgG treatment: experience in Bogotá, Colombia. (Pubmed Central) - Jul 24, 2019
Recruiting --> Active, not recruiting Self-administration of SCIG provided effective protection, favorable tolerability and improved quality of life in patients with PIDs and autoimmune diseases from Colombia.
- | Hemlibra (emicizumab-kxwh) / Roche, Nuwiq (simoctocog alfa) / Octapharma
New P3 trial: The Atlanta Study: Emicizumab PUPs and Nuwiq ITI Study (clinicaltrials.gov) - Jul 22, 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.
- ||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Trial completion: Octagam 5% Versus Comparator Post Marketing Trial (clinicaltrials.gov) - Jun 12, 2019
P=N/A, N=623, Completed, Sponsor: Octapharma
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. Active, not recruiting --> Completed
- | Gammaplex (intravenous normal human immunoglobulin) / Bio Products Laboratory (BPL), Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion, Octagam (intravenous normal human immunoglobulin) / Octapharma
Journal: Two comparative assessments of intravenous immunoglobulin therapy switching patterns in the treatment of chronic inflammatory demyelinating polyneuropathy in the US. (Pubmed Central) - May 25, 2019
However, differences existed in switch rates for different IVIG products. The reason for low switching rates could not be assessed in this study; therefore, further studies are required to detect possible relevant differences in effectiveness and tolerability.
- | Fibryga (fibrinogen concentrate (human)) / Octapharma
Trial completion, Enrollment change, Head-to-Head, Surgery: FIBRES: FIBrinogen REplenishment in Surgery (clinicaltrials.gov) - May 14, 2019
P3, N=827, Completed, Sponsor: University Health Network, Toronto
The reason for low switching rates could not be assessed in this study; therefore, further studies are required to detect possible relevant differences in effectiveness and tolerability. Active, not recruiting --> Completed | N=1200 --> 827
- |||||||| Gammanorm (human immune globulin subcutaneous) / Octapharma
New P3 trial: Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases (clinicaltrials.gov) - May 5, 2019
P3, N=65, Not yet recruiting, Sponsor: Octapharma
- | Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, autologous hematopoietic stem cell therapy / Northwestern University
Trial initiation date: ATTEND: Autologous Transplant To End NMO Spectrum Disorder (clinicaltrials.gov) - May 2, 2019
P2/3, N=50, Recruiting, Sponsor: Northwestern University
Active, not recruiting --> Completed | N=1200 --> 827 Initiation date: Mar 2019 --> Jun 2019
- | 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.
- | Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Journal: Effect of Silane Treatment on Mechanical Properties of Polyurethane/Mesoscopic Fly Ash Composites. (Pubmed Central) - Apr 27, 2019
In view of the accidents such as rock mass breakage, roof fall and coal slide in coal mines, polyurethane/mesoscopic fly ash (PU/MFA) reinforcement materials were produced from polymethylene polyphenylene isocyanate (PAPI), the polyether polyol, flame retardant, and MFA using stannous octanate as a catalyst...The results show that the compression property, fracture toughness, maximum flexural strength, and bond strength of PU/MFA composites increase by 21.6%, 10.1%, 8.8%, and 19.3%, respectively, compared with the values before the modification. Furthermore, the analyses of scanning electron microscope and dynamic mechanics suggest that the coupling agent GPTMS can successfully improve the mechanical properties of PU/MFA composites because it eliminates the stress concentration and exerts a positive effect on the crosslink density and hardness of PU/MFA composites.