Emicizumab PUPs and Nuwiq ITI Study
Public ClinicalTrials.gov record NCT04030052. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04030052
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 17, 2022 (Actual)
- Primary completion
- Jan 19, 2023 (Actual)
- Completion
- Jan 19, 2023 (Actual)
- Last update posted
- Jan 5, 2024
2022 – 2023
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Emory University/Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Mindy_L_Simpson@rush.edu | Indianapolis | Indiana | 46260 | — |
| Children's Hospital of Michigan/ Wayne State University | Detroit | Michigan | 48201 | — |
| Weill Cornell Medicine | New York | New York | 10021 | — |
| University of North Carolina - Hemophilia and Thrombosis Center | Chapel Hill | North Carolina | 27599 | — |
| Verisiti, WI | Milwaukee | Wisconsin | 53233 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04030052, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 5, 2024 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04030052 live on ClinicalTrials.gov.