Long-term safety and efficacy of N8-GP in previously treated pediatric patients with hemophilia A: Final results from pathfinder5.

ABSTRACT:

Background

N8-GP (turoctocog alfa pegol; Esperoct^® , Novo Nordisk A/S, Bagsvaerd, Denmark) is a glycoPEGylated, extended half-life human recombinant factor VIII (FVIII).

Objective

Here, we report end-of-trial safety and efficacy results from the completed N8-GP pathfinder5 trial.

Methods

pathfinder5 (NCT01731600) was a multi-national, open-label, single-arm, non-randomized, non-controlled trial in previously treated male patients aged <12 years old with severe hemophilia A that comprised a main and an extension phase. During the main phase, patients received twice-weekly N8-GP 60 IU/kg for 50 exposure days (~26 weeks). During the extension phase, patients received the same regimen until the end of trial (first patient in main phase, 20 February 2013; trial

SUBMITTER: Saulyte Trakymiene S 

PROVIDER: S-EPMC7540298 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature