Overview

Emicizumab PUPs and Nuwiq ITI Study

Status:
Recruiting

Trial end date:
2025-04-01

Target enrollment:

Participant gender:

Summary

This study prospectively investigates the safety, FVIII immunogenicity, and hemostatic efficacy of prophylactic HEMLIBRA® given with a concomitant low dose recombinant factor VIII (rFVIII) known as NUWIQ®, in HA infants and children <3 years old who have had little to no previous exposure to FVIII. In addition, the study investigates the safety and efficacy of a novel FVIII ITI regimen in children <21 with existing low and high titer inhibitors (LTI and HTI).

Phase:

Phase 3

Details

Lead Sponsor:

Emory University

Collaborator:

Genentech, Inc.

Treatments:

Antibodies, Bispecific
Factor VIII