Emicizumab PUPs and Nuwiq ITI Study

Withdrawn before enrolling · Phase 3

Conditions studied: Hemophilia A

In brief

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).

Key facts

Study ID

NCT04030052

Run by

Emory University

People needed

0

Starts

2022-02-17

Expected to finish

2023-01-19

Last updated by the study team

2024-01-05

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Verisiti, WI — Milwaukee, Wisconsin, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Emory University/Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Mindy_L_Simpson@rush.edu — Indianapolis, Indiana, United States
• Children's Hospital of Michigan/ Wayne State University — Detroit, Michigan, United States
• Weill Cornell Medicine — New York, New York, United States
• University of North Carolina - Hemophilia and Thrombosis Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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