Prophylactic emicizumab for hemophilia A in the Asia-Pacific region: A randomized study (HAVEN 5).

ABSTRACT:

Background

Emicizumab is a subcutaneously administered humanized, bispecific, monoclonal antibody approved for prophylaxis in people with hemophilia A.

Methods

HAVEN 5 (NCT03315455) is a randomized, open-label, phase 3 study of individuals aged ≥12 years with severe hemophilia A without factor VIII (FVIII) inhibitors, or hemophilia A of any severity with FVIII inhibitors, across the Asia-Pacific region. Participants were randomly assigned (2:2:1) to receive emicizumab 1.5 mg/kg once weekly (arm A), emicizumab 6 mg/kg every 4 weeks (arm B), or no prophylaxis (arm C). The primary end point was annualized bleeding rate (ABR) for treated bleeds; ABRs were compared between people receiving emicizumab prophylaxis versus those with no prophylaxis. Secondary end points included ABR

SUBMITTER: Yang R 

PROVIDER: S-EPMC8902287 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature