Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A
Public ClinicalTrials.gov record NCT04644575. 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.
Official title
A Phase 3 Open-label, Multicenter Study of the Long-term Safety and Efficacy of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients With Severe Hemophilia A
Study identification
- NCT ID
- NCT04644575
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Bioverativ, a Sanofi company
- Industry
- Enrollment
- 261 participants
Conditions and interventions
Conditions
Interventions
- efanesoctocog alfa (BIVV001) Drug
Drug
Eligibility (public fields only)
- Age range
- Not listed
- 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 22, 2021
- Primary completion
- Jan 14, 2027
- Completion
- Jan 14, 2027
- Last update posted
- Jul 31, 2025
2021 – 2027
United States locations
- U.S. sites
- 16
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Orthopaedic Institute for Children Site Number : 8400003 | Los Angeles | California | 90007 | — |
| Children's Hospital Los Angeles Site Number : 8400009 | Los Angeles | California | 90027 | — |
| University of California San Diego Site Number : 8400007 | San Diego | California | 92121 | — |
| University of Florida Health Site Number : 8400008 | Gainesville | Florida | 32608 | — |
| Children's Healthcare of Atlanta Site Number : 8400016 | Atlanta | Georgia | 30322 | — |
| Rush University Medical Center Site Number : 8400010 | Chicago | Illinois | 60612-3833 | — |
| Children's Hospital Of Iowa Site Number : 8400011 | Iowa City | Iowa | 52242 | — |
| University of Michigan Medical Center Site Number : 8400006 | Ann Arbor | Michigan | 48109 | — |
| Michigan State University School Of Med Site Number : 8400002 | East Lansing | Michigan | 48824 | — |
| Hemostasis and Thrombosis Center of Nevada Site Number : 8400001 | Las Vegas | Nevada | 89113 | — |
| New York Presbyterian Hospital/Weill Cornell Medical Center Site Number : 8400017 | New York | New York | 10021 | — |
| East Carolina University -2390 Hemby Ln Site Number : 8400015 | Greenville | North Carolina | 27834 | — |
| Cincinnati Children's Hospital Medical Center Site Number : 8400012 | Cincinnati | Ohio | 45229 | — |
| Children's Research Institute Site Number : 8400013 | Columbus | Ohio | 43205-2696 | — |
| Bloodworks Northwest Site Number : 8400005 | Seattle | Washington | 98104 | — |
| Children's Hospital of Wisconsin Site Number : 8400014 | Milwaukee | Wisconsin | 53226-0509 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 69 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04644575, 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 Jul 31, 2025 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04644575 live on ClinicalTrials.gov.