A5057299160- Hemophilia Treatment and Research
- Blood Coagulation and Thrombosis Mechanisms
- Hemostasis and retained surgical items
- Coagulation, Bradykinin, Polyphosphates, and Angioedema
- Chronic Myeloid Leukemia Treatments
- Cancer-related gene regulation
- Platelet Disorders and Treatments
- Protein purification and stability
Bayer (United States)
2015-2020
Discrepancies in the measurement of modified factor VIII (FVIII) products have been recognized, highlighting need for adjustments clinical laboratory practices to ensure effective monitoring patients treated with these products, particularly using one-stage (activated partial thromboplastin time [aPTT]) assay.To assess ability laboratories measure activity BAY 94-9027, a PEGylated extended half-life FVIII product, routine (predominantly one-stage) assays METHODS: Blinded samples...
No head-to-head trials comparing recombinant factor VIII (rFVIII) products currently exist. This was a matching-adjusted indirect comparison (MAIC) study of efficacy BAY 81-8973 with antihemophilic (recombinant) plasma/albumin-free method (rAHF-PFM) and turoctocog alfa for the prophylaxis severe hemophilia A.A systematic literature review conducted to identify rAHF-PFM alfa. Comparisons were using individual patient data (IPD) from LEOPOLD published trials. Differences in outcome reporting...
Introduction BAY 81‐8973 (Kovaltry ® ) is a full‐length, unmodified recombinant human factor VIII approved in China for prophylaxis and on‐demand treatment patients with haemophilia A. Limited access to FVIII has historically led this population being undertreated. This subanalysis of LEOPOLD II investigated whether the efficacy safety varied between Chinese non‐Chinese patients. Aim To evaluate Methods enrolled males aged 12‒65 years severe A who were receiving treatment. Patients randomly...
The Colorado Adult Joint Assessment Scale (CAJAS) is designed to assess joint health in adults with hemophilia. CAJAS comprises nine items (swelling, muscle atrophy, axial deformity, crepitus, range of motion, contracture, instability, strength, gait) and assesses six joints.To content validity psychometric properties.Data were obtained from the Trial Evaluate Effect Secondary Prophylaxis With rFVIII Therapy Severe Hemophilia A and/or Adolescent Subjects Compared That Episodic Treatment...
IntroductionBAY 81-8973 (Kovaltry®), a recombinant factor VIII (rFVIII) product, was efficacious and well tolerated in paediatric previously treated patients (PTPs) with severe haemophilia A for ≥50 exposure days (EDs) the LEOPOLD Kids study. Because long-term prophylaxis (≥100 EDs) can provide substantial patient benefits, FVIII products should demonstrate safety efficacy.AimTo efficacy of BAY PTPs.MethodsPTPs aged ≤12 years without inhibitors could continue ongoing open-label extension...
Abstract Objectives BAY 81‐8973 (Kovaltry ® ), a full‐length, unmodified, recombinant human factor VIII, provided excellent bleeding control for patients with haemophilia A in the pivotal 1‐year LEOPOLD I trial. The extension evaluated long‐term efficacy and safety of prophylaxis. Methods After completing I, continued receiving 20‒50 IU/kg two‐ or three‐times weekly extension. Outcomes included annualised rate (ABR) haemostasis during surgery. Results Fifty‐five aged 12‐65 years participated...