Recombinant clotting factors.
- BiologyThrombosis and haemostasis
Recombinant DNA technology remains the platform to address ongoing challenges in haemophilia care such as reducing the costs of therapy, increasing the availability to the developing world, and improving the functional properties of these proteins.
Immunogenic Determinants of Coagulation Factor VIII
- Biology, Medicine
The first deimmunized FVIII molecule is generated, containing 19 amino acid mutations, which could reduce the probability of inhibitor development, providing a safer therapy for the patients and lower the costs for therapy.
Switching clotting factor concentrates: considerations in estimating the risk of immunogenicity
- MedicineHaemophilia : the official journal of the World Federation of Hemophilia
This review presents the results of a complementary strategy, a Delphi analysis, to add to the considerations of product switching and FVIII immunogenicity.
Plasma derivatives: new products and new approaches.
- BiologyBiologicals : journal of the International Association of Biological Standardization
Challenges for new haemophilia products from a manufacturer's perspective.
- BiologyThrombosis research
New developments in the management of moderate-to-severe hemophilia B
- Biology, MedicineJournal of blood medicine
The biology of FIX, the evolution of FIX replacement therapy, the emerging FIX products possessing extended half-lives, and novel “rebalancing” approaches to hemophilia therapy are discussed.
Safety surveillance in haemophilia and allied disorders
- MedicineJournal of internal medicine
All clinicians treating individuals with inherited bleeding disorders should prospectively report adverse events to treatment even if they are believed to be common and well recognized, as this is the most important issue in haemophilia care today.
Evolution of recombinant factor VIII safety: KOGENATE® and Kogenate® FS/Bayer
- MedicineInternational journal of hematology
Although KOGENATE and Kogenate FS/Bayer are nearly identical products, subtle manufacturing improvements to address the need for greater margins of safety from a pathogen transmission perspective have also led to a potentially improved immunogenicity profile.
Innovative approach for improved rFVIII concentrate
- BiologyEuropean journal of haematology
Large clinical trials seem to confirm the expectations placed in Turoctocog alfa in terms of high quality and safety of recombinant FVIII toward the goal of overcoming actual and future challenges of hemophilia therapy.
SHOWING 1-10 OF 142 REFERENCES
Clinical perspectives of emerging pathogens in bleeding disorders
- Biology, MedicineThe Lancet
The promise and challenges of bioengineered recombinant clotting factors
- BiologyJournal of thrombosis and haemostasis : JTH
The ability to bioengineer recombinant clotting factors with improved function holds promise to overcome some of the limitations in current treatment, the high costs of therapy and increase availability to a broader world hemophilia population.
Production and therapeutic use of a factor XI concentrate from plasma.
- Medicine, BiologyThrombosis and haemostasis
It is concluded that this concentrate provides effective treatment for patients with factor XI deficiency and preliminary results suggest safety from virus transmission, but this needs to be established in further studies of previously untreated patients.
Recombinant factor VIII for the treatment of previously untreated patients with hemophilia A. Safety, efficacy, and development of inhibitors. Kogenate Previously Untreated Patient Study Group.
- MedicineThe New England journal of medicine
Transient or low levels of inhibitor, as observed in this study, may represent part of the natural history of hemophilia in infants and the benefits of recombinant factor VIII for the treatment of hemophile seem to outweigh the risks.
Inhibitors in congenital coagulation disorders
- Medicine, BiologyBritish journal of haematology
The purpose of this review is to summarize current understanding of the epidemiology, immunobiology, laboratory evaluation and management of inhibitors arising in patients with congenital coagulation disorders.
Current therapy for rare factor deficiencies
- Medicine, BiologyHaemophilia : the official journal of the World Federation of Hemophilia
Treatment of rare clotting factor deficiencies consists of the most purified blood product available that contains the missing factor.
Managing the risk of transmission of variant Creutzfeldt Jakob disease by blood products
- MedicineBritish journal of haematology
To reduce the risk of the pathological prion in the UK infecting recipients of clotting factor concentrates, these are now only manufactured from imported plasma collected from countries where there has not been bovine spongiform encephalopathy in cattle and therisk of variant CJD in the population is, therefore, considered negligible.
Hepatitis and clotting-factor concentrates.
- Medicine, BiologyJAMA
The incidence of clinical hepatitis among 482 hemophiliacs treated here in the last ten years is reviewed, finding that in older patients, hepatitis frequently followed the first exposure to concentrate if prior blood and plasma infusions were few.
Recombinant factor VIIa: review of efficacy, dosing regimens and safety in patients with congenital and acquired factor VIII or IX inhibitors
- Medicine, BiologyJournal of thrombosis and haemostasis : JTH
Recombinant factor (rF)VIIa has been available to clinicians since 1996 and has an excellent safety record after almost three‐quarters of a million doses have been administered and thrombotic events have not increased despite a growing experience with higher dosing.
Efficacy and safety of a prothrombin complex concentrate with two virus-inactivation steps in patients with severe liver damage
- Medicine, BiologyEuropean journal of gastroenterology & hepatology
The infusion of pasteurized, nanometre-filtered PCC is an effective, well-tolerated method of correcting prothrombin complex deficiency in patients with severe liver disease with haemorrhage, or before an urgent surgical or invasive diagnostic intervention.