Real-world use of recombinant porcine sequence factor VIII in the treatment of acquired hemophilia A: EU PASS.

ABSTRACT:

Background

Recombinant porcine factor VIII (rpFVIII; susoctocog alfa) is indicated for the treatment of bleeding events (BEs) in adults with acquired hemophilia A (AHA).

Objectives

To assess the safety, utilization, and effectiveness of rpFVIII in clinical practice.

Design

EU post-authorization safety study (PASS) (NCT03199794) was a multicenter, noninterventional, post-authorization safety study conducted in adults with AHA.

Methods

Data were collected retrospectively or prospectively for up to 180 days after the last rpFVIII dose. The primary objective was safety, as assessed by adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs) (e.g. immunogenicity, hypersensitivity reactions, thromboembolic events). Secondary endpoints included im

SUBMITTER: Miesbach W 

PROVIDER: S-EPMC11369870 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature