Confirmed long-term safety and efficacy of prophylactic treatment with BAY 94-9027 in severe haemophilia A: final results of the PROTECT VIII extension study.

ABSTRACT:

Introduction

The phase 2/3 PROTECT VIII main study demonstrated efficacy and safety of BAY 94-9027 (damoctocog alfa pegol; Jivi^® ), a B-domain-deleted recombinant factor VIII (FVIII), site-specifically PEGylated to extend its half-life.

Aim

To report the final efficacy and safety data for BAY 94-9027 from the PROTECT VIII extension.

Methods

Previously treated males aged 12-65 years with severe haemophilia A (FVIII <1%) who completed the multicentre, open-label PROTECT VIII main study were eligible for the extension. Patients received either on demand or prophylaxis treatments (30-40 IU/kg twice weekly [2 × W], 45-60 IU/kg every 5 days [E5D], or 60 IU/kg every 7 days [E7D]) and could switch to any prophylaxis regimen (variable frequency) as needed. Annualise

SUBMITTER: Reding MT 

PROVIDER: S-EPMC9290859 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature