Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: Final results from pathfinder2.

ABSTRACT:

Background

N8-GP (turoctocog alfa pegol; Esperoct^® , Novo Nordisk A/S, Bagsvaerd, Denmark) is a glycoPEGylated human recombinant factor VIII with a half-life of ~1.6-fold of standard FVIII products. pathfinder2 (NCT01480180) was a multi-national, open-label trial of N8-GP in previously treated adolescent and adult patients with severe hemophilia A.

Objective

We report end-of-trial efficacy and safety of N8-GP from pathfinder2.

Methods

pathfinder2 main phase and extension phase part 1 results have been previously reported. During extension phase part 2, patients could switch from N8-GP prophylaxis 50 IU/kg every fourth day (Q4D) or 75 IU/kg once weekly (Q7D), depending on bleeding status. Extension phase part 2 collected long-term safety and efficacy data fo

SUBMITTER: Giangrande P 

PROVIDER: S-EPMC7540590 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature