Safety, pharmacokinetics and efficacy of a subcutaneous recombinant FVIII (OCTA101) in adult patients with severe haemophilia A.

Introduction: Regular, prophylactic intravenous (i.v.) FVIII can be challenging for some patients with haemophilia A.

Factors Influencing the Age of Complementary Feeding-A Cross-Sectional Study from Two European Countries.

The timing of introducing complementary feeding affects nutritional status and children's health. The aim of this study was to determine sociodemographic and birth-related factors associated with the age of introducing complementary foods. This cross-sectional study investigated parents ( = 5815) of children aged 12-36 months from Poland ( = 4065) and Austria ( = 1750) using a single online questionnaire.

Efficacy and safety of simoctocog alfa (Nuwiq®) in patients with severe hemophilia A: a review of clinical trial data from the GENA program.

Simoctocog alfa (human-cl rhFVIII, Nuwiq®) is a 4th generation recombinant FVIII (rFVIII), without chemical modification or fusion with any other protein/fragment. Nuwiq® is produced in a human embryonic kidney cell line (HEK293F), which ensures human-specific post-translational protein processing. Nuwiq® was evaluated in seven prospective clinical studies in 201 adult and pediatric previously treated patients (PTPs) with severe hemophilia A.

Individual thrombin generation and spontaneous bleeding rate during personalized prophylaxis with Nuwiq (human-cl rhFVIII) in previously treated patients with severe haemophilia A.

Introduction: For individuals with haemophilia A, prophylaxis with factor VIII (FVIII) is typically directed towards trough activity >1 IU/dL; however, some patients still experience spontaneous bleeding events (sBEs).

Aim: Aims were to evaluate relationships of endogenous thrombin potential (ETP) and FVIII:C with occurrence of clinical bleeding.

Methods: GENA-21 was a prospective, open-label, phase IIIb study investigating the safety and efficacy of Nuwiq (human-cl rhFVIII) in previously treated adults with severe haemophilia A.

Long-term tolerability, immunogenicity and efficacy of Nuwiq (human-cl rhFVIII) in children with severe haemophilia A.

Introduction: Nuwiq (human-cl rhFVIII, simoctocog alfa) is a 4th generation recombinant human FVIII, without chemical modification or fusion with any other protein, produced in a human cell line.

Aim/methods: This study (GENA-13) was an extension of the GENA-03 study in which previously treated children aged 2-12 years with severe haemophilia A received Nuwiq prophylaxis for ≥6 months. GENA-13 examined long-term tolerability, immunogenicity and efficacy of Nuwiq prophylaxis in children.