Safety and Use of Eptacog Beta 225 µg/kg in Patients With Haemophilia A or B With Inhibitors.

ABSTRACT:

Introduction

Eptacog beta is an activated recombinant human factor VII bypassing agent approved for treating bleeding episodes (BEs) in patients aged ≥12 years with haemophilia A or B with inhibitors. Two initial dose regimens (IDRs) of either 75 or 225 µg/kg, followed by 75 µg/kg, are approved. We examined the safety of eptacog beta 225 µg/kg across completed clinical trials.

Methods

This analysis included data from a Phase 1b trial of single doses of eptacog beta 25, 75 and 225 µg/kg in non-bleeding adults with haemophilia and pooled data from two Phase 3 trials of the 75 and 225 µg/kg IDRs for treating BEs in adolescents and adults (PERSEPT 1) and children (PERSEPT 2).

Results

In the Phase 1b trial, 10 patients received a single eptacog beta infusion at each dose l

SUBMITTER: Carcao M 

PROVIDER: S-EPMC12462549 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature