A5010414629- Hemophilia Treatment and Research
- Coagulation, Bradykinin, Polyphosphates, and Angioedema
- Blood Coagulation and Thrombosis Mechanisms
- Chronic Myeloid Leukemia Treatments
- Platelet Disorders and Treatments
Abstract Introduction Emicizumab is a recombinant humanized bispecific monoclonal antibody mimicking the cofactor function of activated factor VIII. Aim In this multicentre, open‐label study (HOHOEMI), we evaluated efficacy, safety and pharmacokinetics emicizumab in Japanese paediatric patients aged <12 years with severe haemophilia A without VIII (FVIII) inhibitors. Methods was administered subcutaneously, four loading doses 3 mg/kg every week followed by maintenance 2 weeks (Q2W) or 6 4...
Safety and efficacy results of the phase 1 study 1/2 extension bispecific antibody emicizumab in patients with severe haemophilia A or without factor VIII inhibitors for up to 2.8 years were reported previously.To evaluate further longer-term data including patients' perceptions at completion.Emicizumab was administered subcutaneously once weekly maintenance doses 0.3, 3 mg/kg potential up-titration. All later switched approved dose 1.5 mg/kg.Eighteen received 5.8 years. Most adverse events...
Emicizumab is a bispecific antibody mimicking the cofactor function of activated coagulation factor VIII to prevent bleeds in patients with hemophilia A. The dose selection for first-in-child phase III study emicizumab was addressed by pediatric pharmacokinetic prediction using an adult/adolescent population model developed I-I/II studies. modified incorporate functions describing age-dependent increase body weight (BW) or without clearance maturation account differences pharmacokinetics...