Clinical trialNCT04030052WithdrawnPhase 3Interventional

Emicizumab PUPs and Nuwiq ITI Study

SponsorEmory UniversityEnrollment0Hemophilia A

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Robert Sidonio, MD
Emory University
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

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
Verisiti, Wi
Milwaukee, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

HEMLIBRANuwiq

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 17 Feb 2022
Primary completion: 19 Jan 2023
Completion: 19 Jan 2023
Last update posted: 5 Jan 2024
Registered enrollment: 0
Registry id: NCT04030052

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.