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10 Diseases |  |
1 Trial |
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1 Trial |  |
157 News |  |
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- |||| Afstyla (lonoctocog alfa) / CSL Behring
Enrollment open, Trial completion date, Trial primary completion date: Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products (clinicaltrials.gov) - Jan 23, 2025
P3, N=60, Recruiting, Sponsor: CSL Behring
Not yet recruiting --> Recruiting | Trial completion date: Feb 2026 --> Jun 2026 | Trial primary completion date: Feb 2026 --> Jun 2026
- |||||||| Afstyla (lonoctocog alfa) / CSL Behring
New P3 trial: Recombinant single-chain factor VIII (rVIII-SingleChain) in Chinese participants with hemophilia A previously treated with FVIII products (EUDRACT) - Dec 19, 2024
P3, N=60, , Sponsor: CSL Behring
- |||||||| Afstyla (lonoctocog alfa) / CSL Behring
New P3 trial: Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products (clinicaltrials.gov) - Dec 18, 2024
P3, N=60, Not yet recruiting, Sponsor: CSL Behring
- | Afstyla (lonoctocog alfa) / CSL Behring, Advate (octocog alfa) / Takeda
Journal: Comprehensive laboratory assessment of lonoctocog alfa versus octocog alfa in severe haemophilia A. (Pubmed Central) - Nov 13, 2024
Lonoctocog alfa and octocog alfa showed comparable recovery and safety in vivo as well as similar impacts on TG in vitro. Observed assay discrepancies on lonoctocog alfa demonstrated variability of results also between different FVIII CSAs.
- Abstilla (lonoctocog alfa) / CSL Behring
Observational data, Retrospective data, Journal: Switching hemophilia A patients to rVIII-SingleChain: The Iberian experience. (Pubmed Central) - Sep 10, 2024
The real-world outcomes of lonoctocog alfa (rVIII-SingleChain), a long-acting factor VIII (FVIII) with a favorable safety and efficacy profile in trials, were assessed in patients with hemophilia A in Iberian (Spain and Portugal)...No safety concerns were reported. Patients who switched to rVIII-SingleChain prophylaxis had excellent bleeding control and reduced infusion frequency in regular clinical practice, with the subsequent increase in quality-of-life.
- | Journal: Relationship between factor VIII levels and bleeding for rFVIII-SingleChain in severe hemophilia A: A repeated time-to-event analysis. (Pubmed Central) - May 22, 2023
In conclusion, the developed PK-RTTE model adequately described the relationship between dose, FVIII levels and bleeds for rFVIII-SingleChain. The obtained estimates were in agreement with those published for the FVIII concentrates BAY 81-8973 (octocog alfa) and BAY 94-9027 (damoctocog alfa pegol), indicating similar efficacy to reduce bleeding.
- Abstilla (lonoctocog alfa) / CSL Behring
Post-infusion monitoring of Afstyla FVIII replacement therapy (Room:Exhibition) - May 18, 2023 - Abstract #ISTH2023ISTH_1751;
- | Altuviiio (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) / SOBI, Sanofi
Journal: Altuviiio - a longer-acting factor VIII product for hemophilia A. (Pubmed Central) - May 12, 2023
The obtained estimates were in agreement with those published for the FVIII concentrates BAY 81-8973 (octocog alfa) and BAY 94-9027 (damoctocog alfa pegol), indicating similar efficacy to reduce bleeding. No abstract available
- | Journal: Area under the curve: Comparing the value of factor VIII replacement therapies in haemophilia A. (Pubmed Central) - Nov 30, 2022
This analysis concludes that EHL products differ in relative AUC, have a larger AUC compared with standard half-life, and thus, different FVIII levels over time after infusion. This model may aid decision makers in the absence of head-to-head data.
- Abstilla (lonoctocog alfa) / CSL Behring
A Cost Minimization Model of Afsteyela® (Lonoctocog-Alfa) for the Prophylactic Treatment of Pediatric Patients With Haemophilia A, in Mexico (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1749;
A cost-minimization model (fo anual costs) was developed to estimate the treatment cost associated with lonoctocog-alfa, compared to turoctocog-alfa, moroctocog-alfa, octocog-alfa and simoctocog-alfa in pediatric patients with severe Haemophilia-A. For the treatment of patients with severe Haemophilia-A in Mexico, lonoctocog-alfa was a cost-saving option compared to existing rFVII in Mexico from the public payer perspective.
- Performance of FVIII deficient plasma with VWF in the activity measurement of FVIII replacement products in plasma samples using an OSC assay. (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_2150;
Mean FVIII% recoveries across all levels of Advate, Eloctate, Jivi, Novoeight and Wilate were 93, 95, 101, 113 and 95% respectively. The percent recoveries of Afstyla, after x2 conversion, fell within the acceptance criteria for levels of ≥ 0.1 IU/mL but over-estimated at 149.76% at the lowest level of 0.05 IU/mL.
- Annualized Bleeding Rates in Severe Hemophilia on Prophylaxis in a Real-World Setting (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1727;
Median annualized bleeding rate (ABR) and joint ABR of the whole cohort was 4.74 (0.67-14.15) and 3.01 (0-8.36), respectively. Twenty-five patients were treated with EHL, eight of which documented a switch during the observation period.
- AREA UNDER THE CURVE: INDIRECT PRODUCT COMPARISONS BETWEEN FACTOR VIII REPLACEMENT THERAPIES IN HAEMOPHILIA A ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_221;
In Scenarios 1 and 3, Jivi showed the largest AUC, and in Scenario 2, AUCs of EHLs Elocta and Adynovi were larger than Advate. This AUC tool may aid decision makers in comparing the relative value of FVIII concentrates in the absence of head-to-head trials.
- || Afstyla (lonoctocog alfa) / CSL Behring
Enrollment closed: OPERA: Register of Patients With haEmophilia A tReated With Afstyla (clinicaltrials.gov) - Jan 11, 2022
P=N/A, N=62, Active, not recruiting, Sponsor: CSL Behring
This AUC tool may aid decision makers in comparing the relative value of FVIII concentrates in the absence of head-to-head trials. Recruiting --> Active, not recruiting
- | Journal: Monitoring of different factor VIII replacement products using a factor VIII one-stage clotting assay on cobas t 511/711 analysers. (Pubmed Central) - Nov 12, 2021
Recruiting --> Active, not recruiting These data allow the interpretation of FVIII activity results for different FVIII products using the Roche FVIII OSA on the cobas t 511/711 analysers.
- | Journal: Validation of factor VIII activity for monitoring standard and extended half-life products and correlation to thrombin generation assays. (Pubmed Central) - Sep 22, 2021
Our data revealed good correlation and acceptable bias between CSA and OSA using our sets of reagents, methods and analyser in spiked samples. Thrombin generation gave good correlation to CSA-1 factor activity and is a possible complement to factor activity assays.
- || Abstilla (lonoctocog alfa) / CSL Behring, Eloctate (efraloctocog alfa) / Sanofi, SOBI, Advate (octocog alfa) / Takeda
Clinical, Journal: Matching-Adjusted Indirect Comparison of Efficacy and Consumption of rVIII-SingleChain Versus Two Recombinant FVIII Products Used for Prophylactic Treatment of Adults/Adolescents with Severe Haemophilia A. (Pubmed Central) - Sep 17, 2021
Thrombin generation gave good correlation to CSA-1 factor activity and is a possible complement to factor activity assays. Although limited to published information for comparator trials, these results suggest that with an annualized rFVIII consumption comparable to rFVIIIFc, but significantly lower than rAHF-PFM, routine prophylaxis with rVIII-SingleChain is able to maintain a similar ABR and percentage of patients with zero bleeds, attesting to the long-acting nature of rVIII-SingleChain.
- || Clinical, Journal, Real-world evidence: A Real-World Analysis of Commonly Prescribed FVIII Products Based on U.S. Medical Charts: Consumption and Bleeding Outcomes in Hemophilia A Patients. (Pubmed Central) - Jul 4, 2021
The 6 products evaluated showed statistically comparable ABRs and percentage of patients with 0 bleeds for all patients including those with severe disease. rVIII-SingleChain demonstrated lowest mean consumption for all patients, as well as for patients with severe hemophilia A, which may lead to potential savings in health care costs.
- Afstyla (lonoctocog alfa) / CSL Behring
[VIRTUAL] Joint Health Improvement Following a Switch to Prophylaxis with rVIII-SingleChain: A Patient Case (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_1002;
The patient is satisfied with his treatment and has not required any extra infusions despite an active lifestyle. Conclusions : This case report demonstrates an improvement in joint health following the switch to rVIII-SingleChain in a patient with severe hemophilia A and significant joint damage.
- | Journal: Quantitative HLA-class-II/Factor VIII (FVIII) Peptidomic Variation in Dendritic Cells Correlates with the Immunogenic Potential of Therapeutic FVIII Proteins in Hemophilia A. (Pubmed Central) - May 15, 2021
Conclusions : This case report demonstrates an improvement in joint health following the switch to rVIII-SingleChain in a patient with severe hemophilia A and significant joint damage. Our results provide HLAcII peptidomic level explanations for several important clinical observations/issues including the differential immunogenicity of distinct FVIIIs and the role of HLAcII genetics in inhibitor development.
- | Afstyla (lonoctocog alfa) / CSL Behring
Preclinical, Journal: FVIII half-life extension by coadministration of a D'D3 albumin fusion protein in mice, rabbits, rats, and monkeys. (Pubmed Central) - May 15, 2021
At higher doses, the half-life of recombinant FVIII (rVIII-SingleChain) was calculated to be increased 2.6-fold to fivefold compared with rVIII-SingleChain administered alone in rats, rabbits, and cynomolgus monkeys, and it was increased 3.1-fold to 9.1-fold in mice...This finding might be due to scavenging of activated FVIII by the excessive amount of rD'D3-FP which, in turn, might result in a reduced probability of the formation of the tenase complex. This observation underlines the importance of a fine-tuned balance between FVIII and its binding partner, von Willebrand factor, for hemostasis in general.
- || Afstyla (lonoctocog alfa) / CSL Behring
Trial completion date, Trial primary completion date: OPERA: Register of Patients With haEmophilia A tReated With Afstyla (clinicaltrials.gov) - May 10, 2021
P=N/A, N=50, Recruiting, Sponsor: CSL Behring
This observation underlines the importance of a fine-tuned balance between FVIII and its binding partner, von Willebrand factor, for hemostasis in general. Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Dec 2024
- ||||||| Afstyla (lonoctocog alfa) / CSL Behring
Trial completion: An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A (clinicaltrials.gov) - Jan 22, 2021
P3, N=245, Completed, Sponsor: CSL Behring
Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Dec 2024 Active, not recruiting --> Completed
- || Afstyla (lonoctocog alfa) / CSL Behring, Eloctate (efraloctocog alfa) / Sanofi, SOBI
Clinical, Journal: Comparing Factor Use and Bleed Rates in U.S. Hemophilia A Patients Receiving Prophylaxis with 3 Different Long-Acting Recombinant Factor VIII Products. (Pubmed Central) - Jan 9, 2021
In patients aged ≥ 12 years, rVIII-SingleChain prophylaxis may result in an 11.0% and 13.7% lower mean factor consumption than rFVIIIFc and PEG-rFVIII, respectively, representing a potential cost-saving opportunity of 34% in both cases-at the current wholesale acquisition cost of the corresponding products. In addition, in patients using rVIII-SingleChain prophylactically, consumption was reduced compared with their prior products, while bleeding control was well maintained.
- Afstyla (lonoctocog alfa) / CSL Behring
[VIRTUAL] RETROSPECTIVE ANALYSIS OF RVIII‐SINGLECHAIN AND OTHER COMMONLY USED RECOMBINANT FVIII PRODUCTS COMPARING PROPHYLAXIS TREATMENT REGIMENS AND ASSOCIATED CLINICAL OUTCOMES IN HAEMOPHILIA A PATIENTS IN ITALY () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_180;
In addition, in patients using rVIII-SingleChain prophylactically, consumption was reduced compared with their prior products, while bleeding control was well maintained. In this patient‐chart review analysing four rFVIII products, rVIII‐SingleChain demonstrated reliable efficacy, with an ABR (median = 0) similar to that observed in clinical studies, and reduced factor consumption compared to the other products.
- Afstyla (lonoctocog alfa) / CSL Behring
[VIRTUAL] RECOMBINANT FACTOR VIII‐SINGLECHAIN (LONOCTOCOG ALPHA) AS SURGICAL PROPHYLAXIS IN PATIENTS WITH HAEMOPHILIA A. EXPERIENCE OF A REFERENCE HEMOPHILIA CENTER. () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_177;
Introduction: Recombinant factor VIII‐SingleChain (rFVIII‐SC), Afstyla®, design produces a rVIII which is structurally comparable to the endogenous FVIII allowing high intrinsic stability, molecular integrity, faster and enhanced binding to von Willebrand factor (VWF)... In our experience, rFVIII‐SC is a safe and effective treatment choice as a surgical prophylaxis in patients with mild haemophilia A. However, it is necessary to run studies with a larger number of patients to get more solid conclusions.
- Afstyla (lonoctocog alfa) / CSL Behring
[VIRTUAL] REAL‐WORLD EXPERIENCE OF PATIENTS WITH HAEMOPHILIA A SWITCHING TO RVIII‐SINGLECHAIN PROPHYLAXIS IN SPAIN () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_172;
In our experience, rFVIII‐SC is a safe and effective treatment choice as a surgical prophylaxis in patients with mild haemophilia A. However, it is necessary to run studies with a larger number of patients to get more solid conclusions. These are preliminary results from a centre experience in Spain, demonstrating a successful and efficacious switch to rVIII‐SingleChain in patients with haemophilia A of all severities.
- Afstyla (lonoctocog alfa) / CSL Behring
[VIRTUAL] COMPARISON OF FACTOR VIII UTILISATION AND BLEED RATES IN ITALIAN HAEMOPHILIA A PATIENTS WHO SWITCHED TO EXTENDED PROPHYLAXIS DOSING INTERVALS WITH RVIII‐SINGLECHAIN () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_71;
These are preliminary results from a centre experience in Spain, demonstrating a successful and efficacious switch to rVIII‐SingleChain in patients with haemophilia A of all severities. This study suggests that switching patients to treat with rVIII‐SingleChain can reduce their FVIII prophylaxis dosing interval without increasing factor consumption, while maintaining effective bleed prevention consistent with clinical trial results.
- Afstyla (lonoctocog alfa) / CSL Behring
[VIRTUAL] A RETROSPECTIVE REVIEW OF CLINICAL OUTCOMES IN FRENCH PATIENTS WITH HAEMOPHILIA A SWITCHING TO RVIII‐SINGLECHAIN PROPHYLAXIS () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_35;
Patients switching to rVIII‐SC can be well managed, with effective bleed prevention and no increase in factor consumption. These results align with the existing clinical trial findings and real‐world data from Germany and the USA.
- [VIRTUAL] VWF‐CONTAINING FVIII CONCENTRATES IMPROVE FVIII RECOVERY IN A MOUSE MODEL OF SEVERE HAEMOPHILIA WITH INHIBITORS () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_30;
In agreement to previously reported data, native pdFVIII/VWF concentrate was more efficient in the restoration of FVIII circulating levels in FVIIInull E16 KO mice even in the presence of high inhibitor titer. This finding is similar for the different isolated FVIII concentrates analyzed, regardless their origin, molecular form, cell line or involved modifications.
- [VIRTUAL] IN‐HOUSE VALIDATION OF FACTOR VIII ACTIVITY FOR STANDARD AND EXTENDED HALF‐LIFE PRODUCTS AND CORRELATION TO THROMBIN GENERATION ASSAYS () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_11;
The CSA‐1 method gave the least variability compared to the assigned values. In addition, thrombin generation using spiked samples gave excellent correlation to CSA factor activity and identified a thrombin generation method with greater sensitivity towards FVIII in terms of dose response in lag time.
- |||||| Afstyla (lonoctocog alfa) / CSL Behring
New trial: OPERA: Register of Patients With haEmophilia A tReated With Afstyla (clinicaltrials.gov) - Dec 19, 2020
P, N=50, Recruiting, Sponsor: CSL Behring
- || Afstyla (lonoctocog alfa) / CSL Behring, Advate (octocog alfa) / Takeda
Clinical, Clinical data, Journal: Assessing prophylactic use and clinical outcomes in hemophilia A patients treated with rVIII-SingleChain and other common rFVIII products in Germany. (Pubmed Central) - Dec 18, 2020
rVIII-SingleChain prophylaxis provides excellent bleeding protection, with potentially lowest factor consumption among the products assessed. Patients who switched to rVIII-SingleChain prophylaxis reduced dosing frequency and consumption compared with prior treatment, with similar or potentially lower bleeding rates.
- Afstyla (lonoctocog alfa) / CSL Behring
[VIRTUAL] Kasuistiken AFSTYLA () - Dec 18, 2020 - Abstract #GTH2021GTH_55;
Patients who switched to rVIII-SingleChain prophylaxis reduced dosing frequency and consumption compared with prior treatment, with similar or potentially lower bleeding rates. CSL Behring GmbH
- Afstyla (lonoctocog alfa) / CSL Behring
[VIRTUAL] AFSTYLA - a long-acting option in hemophilia A (MAIC data) () - Dec 18, 2020 - Abstract #GTH2021GTH_53;
CSL Behring GmbH CSL Behring GmbH
- |||| Afstyla (lonoctocog alfa) / CSL Behring
Trial completion date, Trial primary completion date: An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A (clinicaltrials.gov) - Aug 21, 2020
P3, N=245, Active, not recruiting, Sponsor: CSL Behring
CSL Behring GmbH Trial completion date: Jul 2025 --> Jan 2021 | Trial primary completion date: Jul 2025 --> Jan 2021
- ||| Trial completion: ATHN 2: Factor Switching Study (clinicaltrials.gov) - Aug 19, 2020
P=N/A, N=310, Completed, Sponsor: American Thrombosis and Hemostasis Network
Trial completion date: Jul 2025 --> Jan 2021 | Trial primary completion date: Jul 2025 --> Jan 2021 Active, not recruiting --> Completed
- Afstyla (lonoctocog alfa) / CSL Behring
[VIRTUAL] Use of rVIII-SingleChain in the Real World (Virtual Meeting Room 2) - Jun 27, 2020 - Abstract #ISTH2020ISTH_3034;
- Afstyla (lonoctocog alfa) / CSL Behring
[VIRTUAL] The Evidence for rVIII-SingleChain (Virtual Meeting Room 2) - Jun 27, 2020 - Abstract #ISTH2020ISTH_3033;
- || Afstyla (lonoctocog alfa) / CSL Behring
Clinical, Journal: Switching patients in the age of long-acting recombinant products? (Pubmed Central) - Jun 12, 2020
The pharmacokinetic, safety and efficacy data for long-acting recombinant products are reviewed, with a focus on recombinant factor IX albumin fusion protein (rIX-FP) and rVIII-SingleChain...Regimens should address patients' needs and goals but should also be guided by clinical phenotype and pharmacokinetic assessment. Follow-up should assess safety concerns, bleeding rates, joint health and the impact of the regimen on patients' lifestyle.
- Afstyla (lonoctocog alfa) / CSL Behring
[VIRTUAL] Treatment of Hemophilia A with rVIII-SingleChain in Italy: Physician and Patient Survey (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_1015;
This survey suggested that switching to rVIII-SingleChain allowed patients to reduce their dosing frequency without increasing factor consumption or compromising protection. Both physicians and patients reported a positive experience with rVIII-SingleChain after at least 1 year of treatment.
- Afstyla (lonoctocog alfa) / CSL Behring
[VIRTUAL] Real-World Experience of rVIII-SingleChain Treatment in a French Single Center (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_949;
Both physicians and patients reported a positive experience with rVIII-SingleChain after at least 1 year of treatment. In accordance with former clinical studies and recent real life use in Germany, this study consolidates rVIII-SingleChain as an extended half-life rFVIII that improves PK parameters, prophylaxis regimen and patient quality of life.
- Afstyla (lonoctocog alfa) / CSL Behring
[VIRTUAL] Haemostatic Efficacy of rVIII-SingleChain in a Case of Surgical Prophylaxis for Hip Replacement (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_920;
In accordance with former clinical studies and recent real life use in Germany, this study consolidates rVIII-SingleChain as an extended half-life rFVIII that improves PK parameters, prophylaxis regimen and patient quality of life. In line with results obtained during the AFFINITY trial, this case report reinforced that rVIII-SingleChain is safe and effective to achieve and maintain haemostatic control during orthopedic surgical prophylaxis in haemophilia A patients.
- Afstyla (lonoctocog alfa) / CSL Behring
[VIRTUAL] Prophylactic Factor VIII Consumption and Clinical Outcomes in Italian Hemophilia A Patients who Switched to Extended Dosing Intervals with Long-Acting rVIII-SingleChain: A Retrospective Patient Chart Review (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_877;
In line with results obtained during the AFFINITY trial, this case report reinforced that rVIII-SingleChain is safe and effective to achieve and maintain haemostatic control during orthopedic surgical prophylaxis in haemophilia A patients. This study shows that rVIII-SingleChain allows patients to use extended treatment intervals without increase in factor utilization and with effective bleed prevention consistent with clinical trial results.
- Afstyla (lonoctocog alfa) / CSL Behring, Advate (octocog alfa) / Takeda
[VIRTUAL] Comparison of FVIII Prophylaxis Treatment Regimen and Associated Clinical Outcomes between rVIII-SingleChain and Other rFVIII Products Commonly Used in Italian Hemophilia A Patients (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_876;
This study shows that rVIII-SingleChain allows patients to use extended treatment intervals without increase in factor utilization and with effective bleed prevention consistent with clinical trial results. In a patient-chart review including four rFVIII products rVIII-SingleChain shows convincing efficacy, real-life ABR (median=0) similar to that observed in clinical studies with a reduced factor consumption, thereby achieving cost-saving while providing excellent patient outcomes.
- Afstyla (lonoctocog alfa) / CSL Behring, Jivi (damoctocog alfa pegol) / Bayer, Adynovate (rurioctocog alfa pegol) / Nektar Therapeutics, Takeda
[VIRTUAL] Monitoring of Different FVIII Replacement Drugs Using the FVIII One-stage Clotting Assay on Cobas t 511/711 Analyzers (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_636;
Overall, most of the FVIII replacement drugs can be reliably measured with the FVIII assay on cobas t 511/711 analyzers without the need for a product specific reference standard. The recorded data set allows the interpretation of FVIII assay results of samples containing different FVIII products on cobas t 511/711 analyzers.
- || Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: ATHN 2: Factor Switching Study (clinicaltrials.gov) - Feb 5, 2020
P=N/A, N=310, Active, not recruiting, Sponsor: American Thrombosis and Hemostasis Network
The recorded data set allows the interpretation of FVIII assay results of samples containing different FVIII products on cobas t 511/711 analyzers. Recruiting --> Active, not recruiting | N=600 --> 310 | Trial completion date: Jan 2022 --> Jun 2020 | Trial primary completion date: Aug 2021 --> Jun 2020
- Afstyla (lonoctocog alfa) / CSL Behring
Switching to extended dosing intervals with long‐acting rVIII‐SingleChain: Clinical outcomes and consumption in german haemophilia A patients () - Feb 4, 2020 - Abstract #EAHAD2020EAHAD_415;
This real‐world data demonstrated that rVIII‐SingleChain allowed patients to extend their treatment intervals and reduce factor consumption, without compromising efficacy. These results confirm rVIII‐SingleChain as a treatment option for hemophilia A patients that provides effective bleed prevention with predictable FVIII consumption.
- Afstyla (lonoctocog alfa) / CSL Behring, Advate (octocog alfa) / Takeda
Prophylactic FVIII treatment regimen and clinical outcomes in german haemophilia a patients: Comparison of rVIII‐SingleChain and other rFVIII products () - Feb 4, 2020 - Abstract #EAHAD2020EAHAD_414;
Haemophilia Treatment Centres provided anonymised patient chart data for 225 patients, 76 with severe haemophilia A. Patients received prophylactic treatment with any of the following rFVIII products for at least 8 weeks – rVIII‐SingleChain (40), rFVIIIFc (47), octocog alfa (58), BAY 81‐8973 (40) and moroctocog alfa (40)... rVIII‐SingleChain demonstrated reduced factor consumption with real‐life ABR (median = 0) similar to that observed in clinical studies, thereby offering potential for cost saving while providing excellent patient outcomes.
- Efficacy and factor consumption of long‐acting recombinant factor VIII products for prophylactic treatment of haemophilia a: a systematic review () - Feb 4, 2020 - Abstract #EAHAD2020EAHAD_384;
Within the limitation of lack of head‐to‐head trials, this review identified suitable data for an indirect comparison of LA rFVIII products. A formal indirect statistical comparison may help to understand how these products could compare with respect to the parameters of ABR, AsBR, AjBR and consumption of rFVIII.