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16 Products |  |
56 Diseases | | 16 Products |
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40 Trials |  |
926 News |  |
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- | Fibryga (fibrinogen concentrate (human)) / Octapharma
Journal: Are all fibrinogen concentrates the same? The effects of two fibrinogen therapies in an afibrinogenemic patient and in a fibrinogen deficient plasma model. A clinical and laboratory case report. (Pubmed Central) - Jun 14, 2024
Our report offers insights into the differential effects of these concentrates, at the clot level, according to the variable constituents of each product, thereby emphasizing that the choice of fibrinogen concentrate can influence the stability of a clot in vivo. Whether this alters clinical efficacy is yet to be understood.
- Wilate (human factor VIII/von Willebrand factor) / Octapharma
Efficacy and Safety of Prophylaxis with a Plasma-derived von Willebrand Factor/Factor VIII Concentrate in Type 3 Patients with von Willebrand Disease (Ballroom B4) - May 17, 2024 - Abstract #ISTH2024ISTH_2212;
P3
Whether this alters clinical efficacy is yet to be understood. Background: The WIL-31 study (NCT04052698) demonstrated the efficacy and safety of regular prophylaxis with a plasma-derived von Willebrand factor/factor VIII concentrate (pdVWF/FVIII; wilate
- Wilate (human factor VIII/von Willebrand factor) / Octapharma
Bleeding Sites in von Willebrand Disease Patients on Prophylaxis with a Plasma-derived von Willebrand Factor/Factor VIII Concentrate (Ballroom B3) - May 17, 2024 - Abstract #ISTH2024ISTH_2162;
P3
Background: The WIL-31 study (NCT04052698) demonstrated the efficacy and safety of regular prophylaxis with a plasma-derived von Willebrand factor/factor VIII concentrate (pdVWF/FVIII; wilate Background: The WIL-31 study (NCT04052698) demonstrated the efficacy and safety of prophylaxis with a plasma-derived von Willebrand factor/factor VIII concentrate (pdVWF/FVIII; wilate
- Factor VIII is a regulator of angiogenesis and a promoter of endothelial barrier stability (111 A-C) - May 17, 2024 - Abstract #ISTH2024ISTH_2032;
A significant enhancement of EC functionality was demonstrated by treating HA BOECs with rFVIII products, with a higher positive effect for simoctocog alfa. Moreover, in NSG-HA mice treated with different rFVIII concentrates, and subsequently injected with Evans Blue dye, we showed a significant reduction of dye extravasation with a complete correction in mice treated with simoctocog alfa compared with other rFVIII products.
- Hemlibra (emicizumab-kxwh) / Roche, Nuwiq (simoctocog alfa) / Octapharma
miRNA expression profiles as a potential biomarker of joint and bone health in haemophilia A (111 A-C) - May 17, 2024 - Abstract #ISTH2024ISTH_2031;
The validation study evaluated these 2 miRNAs. The results demonstrated that two miRNAs (miR- 208a-3p and 524-3p) were significantly underexpressed in plasma of patients with HArt compared to patients without arthropathy, with FDR < 0.05 (Figure 1).
- Nuwiq (simoctocog alfa) / Octapharma
Impact of differential binding of recombinant factor VIII concentrates to platelets on platelet clotting functionality (210 A-D) - May 17, 2024 - Abstract #ISTH2024ISTH_1987;
Through a time-course analysis, we found that rFVIII interaction occurs already in proaggregatory platelets. This early interaction upregulates the intracellular signalling cascade leading to an increased shift from proaggregatory to procoagulant phenotype.
- Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
Prothrombin complex concentrate for prophylaxis in a patient with Factor II deficiency, a case report (Exhibition Hall) - May 17, 2024 - Abstract #ISTH2024ISTH_1266;
This early interaction upregulates the intracellular signalling cascade leading to an increased shift from proaggregatory to procoagulant phenotype. We initiated prothrombin complex concentrate (Octaplex
- Hemlibra (emicizumab-kxwh) / Roche
Successful Management of Recurrent Ankle Hemarthrosis in a Patient with Von Willebrand Disease Type 3 using Emicizumab: A Case Report (Exhibition Hall) - May 17, 2024 - Abstract #ISTH2024ISTH_962;
Recurrent mucocutaneous bleeds, hemarthrosis, and a right ankle target joint significantly impacted the patient's quality of life. Genetic analysis confirmed a homozygous insertion mutation in the VWF gene.
- Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi, Nuwiq (simoctocog alfa) / Octapharma
Indirect comparison of prophylaxis efficacy between simoctocog alfa and efanesoctocog alfa in severe hemophilia A and their cost in the United States (Exhibition Hall) - May 17, 2024 - Abstract #ISTH2024ISTH_928;
The mean weekly dose was significantly higher in patients treated with simoctocog alfa versus efanesoctocog alfa (98.3 IU/kg vs 52.2 IU/kg; p< 0.001). The median dosing interval in the NuPreviq study was 3.5 days; patients in the XTEND-1 study were treated once-weekly.
- Octagam (intravenous normal human immunoglobulin) / Octapharma
EFFICACY IN INFECTION PROPHYLAXIS AND SAFETY OF INTRAVENOUS IMMUNOGLOBULINS IN PATIENTS WITH HYPOGAMMAGLOBULINEMIA DUE TO HEMATOLOGICAL MALIGNANCIES: RESULTS FROM A NON-INTERVENTIONAL STUDY (Poster Area (Hall 7)) - May 15, 2024 - Abstract #EHA2024EHA_4037;
The median dosing interval in the NuPreviq study was 3.5 days; patients in the XTEND-1 study were treated once-weekly. Both 5% and 10% IVIG-preparations were effective in reducing the frequency of infections and well tolerated inpatients with SID resulting from hematological malignancies and those treated with rituximab, with a favorablesafety profile.
- Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
PROTHROMBIN COMPLEX CONCENTRATE USAGE IN UNIVERSITY COLLEGE LONDON HOSPITALS, A RETROSPECTIVE AUDIT (Poster Area (Hall 7)) - May 15, 2024 - Abstract #EHA2024EHA_3347;
Both 5% and 10% IVIG-preparations were effective in reducing the frequency of infections and well tolerated inpatients with SID resulting from hematological malignancies and those treated with rituximab, with a favorablesafety profile. Aims: -Assessment of the use of PCC Prothrombin Complex Concentrate (Octaplex
- || Nuwiq (simoctocog alfa) / Octapharma
Review, Journal: Simoctocog alfa (Nuwiq (Pubmed Central) - May 13, 2024
Optimal care of children should consider several factors, including minimization of inhibitor development risk, maintaining tolerance to FVIII, highly effective bleed prevention and treatment, safety, and impact on long-term outcomes such as bone and joint health. In this context we review the pediatric clinical data and ongoing studies with simoctocog alfa.
- Octagam (intravenous normal human immunoglobulin) / Octapharma
The many faces of primary immune deficiency in childhood (Poster Zone) - Apr 21, 2024 - Abstract #EAACI2024EAACI_2542;
Replacement therapy with human immunoglobulin (Octagam 10%) and isoprinosine was started at the age of 5 years and 4 months...The identification of defects in specific molecules or molecular signaling pathways has led to opportunities to apply targeted treatments that have proven particularly effective in controlling disease and improving health. ?ey words: immune deficiency, immune dysregulation, lymphoma, replacement therapy
- Octagam (intravenous normal human immunoglobulin) / Octapharma
Unveiling the Connection Between ?-Gal Allergy and Cardiovascular Disease (Cordoba) - Apr 5, 2024 - Abstract #EAACI2024EAACI_554;
?ey words: immune deficiency, immune dysregulation, lymphoma, replacement therapy Method For this, anti-?-Gal IgG antibodies were purified from a commercial intravenous human IgG concentrate (Octagam
- Kcentra (plasma-derived prothrombin complex concentrate) / CSL Behring, Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
An investigational four-factor prothrombin complex concentrate for vitamin k antagonist reversal: hemostatic efficacy and safety demonstrated with and without concurrent vitamin k therapy () - Mar 18, 2024 - Abstract #ISICEM2024ISICEM_1008;
Method For this, anti-?-Gal IgG antibodies were purified from a commercial intravenous human IgG concentrate (Octagam LEX -209 was a Phase 3 non -inferiority randomized control trial of an investigational 4F -PCC (Octaplex
- Fibryga (fibrinogen concentrate (human)) / Octapharma
Forma-10 sub-analysis: a real-world, retrospective, observational study of fibrinogen concentrate in patients with trauma-related bleeding and fibrinogen deficiency () - Mar 18, 2024 - Abstract #ISICEM2024ISICEM_1007;
LEX -209 was a Phase 3 non -inferiority randomized control trial of an investigational 4F -PCC (Octaplex This contemporary, real -life data set indicates that fibrinogen concentrate is successfully used in the management of non -surgical trauma -related bleeding in a European healthcare setting.
- Octagam (intravenous normal human immunoglobulin) / Octapharma
Evaluation of Autoantibody Status Effect on Dermatomyositis Patients' Response to IVIG Treatment: Post-hoc Analysis of the ProDERM Trial (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_2863;
This contemporary, real -life data set indicates that fibrinogen concentrate is successfully used in the management of non -surgical trauma -related bleeding in a European healthcare setting. IVIg appears to be an effective agent for treatment of dermatomyositis, regardless of autoantibody status of the patient.
- |||| Panzyga (human immune globulin intravenous 10% stabilised with glycine) / Octapharma
Trial completion date, Trial primary completion date: PROSID: Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study) (clinicaltrials.gov) - Mar 6, 2024
P3, N=240, Recruiting, Sponsor: Octapharma
IVIg appears to be an effective agent for treatment of dermatomyositis, regardless of autoantibody status of the patient. Trial completion date: Oct 2024 --> Aug 2025 | Trial primary completion date: Oct 2024 --> Aug 2025
- | warfarin / Generic mfg.
Journal: Balfaxar: Another four-factor PCC for warfarin reversal. (Pubmed Central) - Mar 2, 2024
Trial completion date: Oct 2024 --> Aug 2025 | Trial primary completion date: Oct 2024 --> Aug 2025 No abstract available
- Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi, Nuwiq (simoctocog alfa) / Octapharma
INDIRECT COMPARISON OF PROPHYLAXIS EFFICACY BETWEEN SIMOCTOCOG ALFA AND EFANESOCTOCOG ALFA IN SEVERE HEMOPHILIA A AND THEIR COST IN THE UNITED STATES (Riverwalk AB; Virtual) - Mar 2, 2024 - Abstract #THSNA2024THSNA_287;
Based on MAIC, prophylaxis with simoctocog alfa resulted in similar zero bleed rates and total ABR as with efanesoctocog alfa, albeit with a higher weekly dose. Despite higher dosing, simoctocog alfa endured an estimated 29% lower cost burden than efanesoctocog alfa.
- Atenativ (human antithrombin III) / Octapharma
A PHASE 3, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF HUMAN PLASMA DERIVED ANTITHROMBIN (ATENATIV) IN HEPARIN-RESISTANT CARDIAC SURGERY PATIENTS (Riverwalk AB; Virtual) - Mar 2, 2024 - Abstract #THSNA2024THSNA_128;
Despite higher dosing, simoctocog alfa endured an estimated 29% lower cost burden than efanesoctocog alfa. Exclusion criteria include patients who have received anticoagulant therapies directly prior to the study, including warfarin, direct oral anticoagulants, ticlopidine,
- Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
A PHASE 3, RANDOMIZED, ACTIVE-CONTROL STUDY OF FOUR-FACTOR PROTHROMBIN COMPLEX CONCENTRATE VERSUS FROZEN PLASMA IN BLEEDING ADULT CARDIAC SURGERY PATIENTS (Riverwalk AB; Virtual) - Mar 2, 2024 - Abstract #THSNA2024THSNA_120;
P3
The study findings have the potential to improve clinical approaches to bleeding management in cardiac surgery patients. Optimizing the management of bleeding related to coagulation factor deficiency may reduce the need for allogeneic blood products and has the potential to improve outcomes in surgical patients.
- RiaSTAP (fibrinogen concentrate (human)) / CSL Behring, Fibryga (fibrinogen concentrate (human)) / Octapharma
PROPHYLACTIC OR POST-TRAUMATIC TREATMENT OF HYPOFIBRINOGENEMIA AND DYSFIBRINOGENEMIA WITH FIBRGYA IN EIGHT CLINICAL CASES (Riverwalk AB; Virtual) - Mar 2, 2024 - Abstract #THSNA2024THSNA_76;
The post procedural bleeding noted in one patient may have been due to inadequate fibrinogen concentration or other comorbid conditions. Further clinical studies are needed to determine the role of FIBRGYA and other HFC in the treatment of patients with CFD.
- ||||| Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
Enrollment change, Trial completion date, Trial primary completion date: LEX-210: Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor (clinicaltrials.gov) - Feb 29, 2024
P3, N=260, Recruiting, Sponsor: Octapharma
Further clinical studies are needed to determine the role of FIBRGYA and other HFC in the treatment of patients with CFD. N=200 --> 260 | Trial completion date: Feb 2024 --> Dec 2024 | Trial primary completion date: Jan 2024 --> Dec 2024
- | Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
Biomarker, Journal, Next-generation sequencing, Microsatellite instability, IO biomarker: An innovative and accurate next-generation sequencing-based microsatellite instability detection method for colorectal and endometrial tumors. (Pubmed Central) - Feb 26, 2024
N=200 --> 260 | Trial completion date: Feb 2024 --> Dec 2024 | Trial primary completion date: Jan 2024 --> Dec 2024 This new NGS-based MSI detection method outperforms previously published methods (i.e. Idylla, OncoMate MSI Dx, and Foundation One
- | Nuwiq (simoctocog alfa) / Octapharma
Journal: Plain language summary for MAIC versus EHL manuscript "Clinical efficacy of simoctocog alfa versus extended half-life recombinant FVIII concentrates in hemophilia A patients undergoing personalized prophylaxis using a matching-adjusted indirect comparison method". (Pubmed Central) - Feb 19, 2024
This new NGS-based MSI detection method outperforms previously published methods (i.e. Idylla, OncoMate MSI Dx, and Foundation One No abstract available
- Nuwiq (simoctocog alfa) / Octapharma
Enrollment open, Trial initiation date: NuPOWER: Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study (clinicaltrials.gov) - Jan 25, 2024
P4, N=28, Recruiting, Sponsor: Octapharma
No abstract available Not yet recruiting --> Recruiting | Initiation date: Oct 2023 --> Feb 2024
- Nuwiq (simoctocog alfa) / Octapharma
Trial initiation date, Surgery: Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery (clinicaltrials.gov) - Jan 23, 2024
P4, N=28, Not yet recruiting, Sponsor: Octapharma
Not yet recruiting --> Recruiting | Initiation date: Oct 2023 --> Feb 2024 Initiation date: Oct 2023 --> Feb 2024
- | Wilate (human factor VIII/von Willebrand factor) / Octapharma
Journal: Von Willebrand factor/factor VIII concentrate (wilate (Pubmed Central) - Jan 18, 2024
P, P3
Initiation date: Oct 2023 --> Feb 2024 Overall, WIL-31 showed that wilate
- || simoctocog alpha/von Willebrand Factor (OCTA101) / Octapharma
PK/PD data, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: Safety, pharmacokinetics and efficacy of a subcutaneous recombinant FVIII (OCTA101) in adult patients with severe haemophilia A. (Pubmed Central) - Jan 16, 2024
P1/2
Despite promising PK and efficacy results, the trial was terminated due to the incidence of FVIII inhibitors. The occurrence of inhibitors at two dose levels suggests that their development may be related to the subcutaneous route of administration.
- Panzyga (human immune globulin intravenous 10% stabilised with glycine) / Octapharma
Enrollment closed: Study to Evaluate the Efficacy and Safety of PANZYGA in Pediatric Patients With Chronic Immune Thrombocytopenia (ITP) (clinicaltrials.gov) - Jan 11, 2024
P4, N=20, Active, not recruiting, Sponsor: Octapharma
The occurrence of inhibitors at two dose levels suggests that their development may be related to the subcutaneous route of administration. Recruiting --> Active, not recruiting
- Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
TWENTY YEARS OF 4-FACTOR PROTHROMBIN COMPLEX CONCENTRATE: REVIEW AND ADVANCES OF OCTAPLEX/BALFAXAR () - Jan 4, 2024 - Abstract #SCCM2024SCCM_960;
- || ASP7317 / Octapharma, CHA Bio & Diostech, Astellas
Phase classification, Enrollment change, Trial completion date, Trial primary completion date: A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration (clinicaltrials.gov) - Jan 2, 2024
P1, N=42, Recruiting, Sponsor: Astellas Institute for Regenerative Medicine
Recruiting --> Active, not recruiting Phase classification: P1b --> P1 | N=18 --> 42 | Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Dec 2025
- | Wilate (human factor VIII/von Willebrand factor) / Octapharma
Trial completion date, Trial primary completion date: Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease VWD) Patients <6 Years of Age (clinicaltrials.gov) - Dec 31, 2023
P3, N=12, Active, not recruiting, Sponsor: Octapharma
- ||| Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
Trial completion date, Trial primary completion date: Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor (clinicaltrials.gov) - Dec 15, 2023
P3, N=200, Recruiting, Sponsor: Octapharma
- |||| Panzyga (human immune globulin intravenous 10% stabilised with glycine) / Octapharma
Trial completion date, Trial primary completion date: PROSID: Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study) (clinicaltrials.gov) - Dec 15, 2023
P3, N=240, Recruiting, Sponsor: Octapharma
- | Panzyga (human immune globulin intravenous 10% stabilised with glycine) / Octapharma
Trial completion date, Trial primary completion date: IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies (clinicaltrials.gov) - Dec 6, 2023
P2, N=20, Not yet recruiting, Sponsor: Henry Ford Health System
- || Wilate (human factor VIII/von Willebrand factor) / Octapharma
Enrollment closed: Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease VWD) Patients <6 Years of Age (clinicaltrials.gov) - Nov 21, 2023
P3, N=12, Active, not recruiting, Sponsor: Octapharma
Phase classification: P1b --> P1 | N=18 --> 42 | Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Dec 2025 Recruiting --> Active, not recruiting
- Wilate (human factor VIII/von Willebrand factor) / Octapharma
Efficacy of Regular Prophylaxis with a Plasma-Derived Von Willebrand Factor/Factor VIII Concentrate in Reducing Heavy Menstrual Bleeding in Females with Von Willebrand Disease (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5415;
P3
A recent prospective study found that recombinant VWF was not superior to tranexamic acid at reducing HMB in women with VWD. The WIL-31 study demonstrated the efficacy of prophylaxis with a plasma-derived VWF/factor VIII (pdVWF/FVIII) concentrate containing VWF and FVIII in a 1:1 activity ratio (wilate
- Wilate (human factor VIII/von Willebrand factor) / Octapharma
Efficacy and Safety of Prophylaxis with a Plasma-Derived Von Willebrand Factor/Factor VIII Concentrate in Children and Adolescents with Von Willebrand Disease (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5410;
P3
The WIL-31 study demonstrated the efficacy of prophylaxis with a plasma-derived VWF/factor VIII (pdVWF/FVIII) concentrate containing VWF and FVIII in a 1:1 activity ratio (wilate The WIL-31 study demonstrated the efficacy of prophylaxis with a plasma-derived VWF/factor VIII (pdVWF/FVIII) concentrate containing VWF and FVIII in a 1:1 activity ratio (wilate
- Nuwiq (simoctocog alfa) / Octapharma
Factor VIII Is an Endothelial Factor That Promotes Vessel Stability (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5394;
In conclusion, information about the possible extra-coagulative role of FVIII may be crucial to understand the key molecular targets missing in HA patients at the cellular level that impair EC functionality. Knowledge of the possible effect of different rFVIII products on ECs functionality can lead to new therapeutic approaches potentially resulting in safer and more efficient treatment of HA.
- Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
Updated Protocol for the Phase 3, Randomized, Double-Blinded Lex-210 Study of Four-Factor Prothrombin Complex Concentrate in Patients with Acute Major Bleeding on Factor Xa Inhibitor Therapy (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_1652;
P3
Knowledge of the possible effect of different rFVIII products on ECs functionality can lead to new therapeutic approaches potentially resulting in safer and more efficient treatment of HA. This study aims to evaluate superior hemostatic efficacy of high-dose vs low-dose four-factor (4F) PCC (Octaplex
- Hemlibra (emicizumab-kxwh) / Roche, Nuwiq (simoctocog alfa) / Octapharma
Design of an Observational Study (PROVE) to Assess the Long-Term Effects of Prophylaxis with Simoctocog Alfa or Emicizumab on Joint and Bone Health in Hemophilia a Patients (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_1651;
This study aims to evaluate superior hemostatic efficacy of high-dose vs low-dose four-factor (4F) PCC (Octaplex The PROVE study aims to generate real-world data on the long-term effects of prophylaxis with simoctocog alfa or emicizumab on joint and bone health in hemophilia A.
- Impact of Recombinant Factor VIII and Platelet Interaction on Platelet Functionality and Hemophilia a Treatment (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_1640;
The increased binding of simoctocog alfa was associated with a phenotypic shift in platelets as evidenced by increased exposure of PS on the platelet membranes. The binding of simoctocog alfa to platelets was disrupted when integrin aIIb
- Nuwiq (simoctocog alfa) / Octapharma
Transcriptomic Profiling to Understand Inhibitor Development in Previously Untreated Patients with Severe Hemophilia a (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_1623;
P3
Inhibitor patients demonstrated alterations in ribosomal protein expression that could disrupt protein synthesis efficiency, protein folding and quality control processes, and trigger cellular stress responses. Inhibitor patients also showed an upregulation of B-cell mediated factors involved in adaptive immune mechanisms.
- || Wilate (human factor VIII/von Willebrand factor) / Octapharma, Nuwiq (simoctocog alfa) / Octapharma, Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Enrollment change: Protect-NOW: Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients (clinicaltrials.gov) - Nov 2, 2023
P=N/A, N=200, Recruiting, Sponsor: Octapharma
Inhibitor patients also showed an upregulation of B-cell mediated factors involved in adaptive immune mechanisms. N=140 --> 200
- ||||| Wilate (human factor VIII/von Willebrand factor) / Octapharma
Enrollment change: WIL-31: Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With VWD (clinicaltrials.gov) - Oct 25, 2023
P3, N=43, Completed, Sponsor: Octapharma
N=140 --> 200 N=28 --> 43
- | Octagam (intravenous normal human immunoglobulin) / Octapharma
Retrospective data, Journal: Efficacy of intravenous immunoglobulins (IVIg) in improving skin symptoms in patients with dermatomyositis: a post-hoc analysis of the ProDERM study. (Pubmed Central) - Oct 6, 2023
P3
N=28 --> 43 In the First Period (Weeks 0-16), adults with active DM received 2.0
- || Panzyga (human immune globulin intravenous 10% stabilised with glycine) / Octapharma
Enrollment open: NGAM-11: Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients (clinicaltrials.gov) - Oct 6, 2023
P3, N=30, Recruiting, Sponsor: Octapharma
In the First Period (Weeks 0-16), adults with active DM received 2.0 Not yet recruiting --> Recruiting
- | Hemlibra (emicizumab-kxwh) / Roche, Nuwiq (simoctocog alfa) / Octapharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: The Atlanta Study: Emicizumab PUPs and Nuwiq ITI Study (clinicaltrials.gov) - Oct 4, 2023
P3, N=2, Terminated, Sponsor: Emory University
Not yet recruiting --> Recruiting N=60 --> 2 | Trial completion date: Apr 2025 --> Jan 2023 | Recruiting --> Terminated | Trial primary completion date: Apr 2025 --> Jan 2023; The Emi PUPs and Nuwiq ITI study has been closed due to slow enrollment and study site startup.