Zero incidence of factor VIII inhibitors and successful haemostatic response in previously factor VIII-treated patients with haemophilia A switching to turoctocog alfa in a noninterventional study.

ABSTRACT:

Introduction

Turoctocog alfa (NovoEight^® ) is a B-domain-truncated recombinant factor VIII (FVIII) approved for patients with haemophilia A.

Aim

To investigate the long-term safety and efficacy of turoctocog alfa in routine clinical practice.

Methods

Guardian 5 was a prospective, multinational, non-interventional, post-authorisation safety study. Male previously treated patients (> 150 exposure days [EDs]) of any age with severe/moderately severe haemophilia A (FVIII ≤ 2%) and a negative inhibitor test prior to first dosing (independent of FVIII-inhibitor history) were included to receive prophylaxis or on-demand treatment. The primary endpoint was the proportion of patients developing FVIII inhibitors (≥.6 Bethesda Units [BU]) after baseline visit, measure

SUBMITTER: Escuriola Ettingshausen C 

PROVIDER: S-EPMC9298792 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature