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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: \- To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia A Secondary Objectives: * To evaluate the efficacy of BIVV001 as a prophylaxis treatment. * To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes. * To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes. * To evaluate the effect of BIVV001 prophylaxis on joint health outcomes. * To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes. * To evaluate the safety and tolerability of BIVV001 treatment. * To assess the PK of BIVV001 based on the one stage activated partial thromboplastin time (aPTT) and two-stage chromogenic FVIII activity assays (only applicable to Arm B). * To evaluate the efficacy of BIVV001 for perioperative management
Study identification
- NCT ID
- NCT04644575
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 261 participants
Conditions and interventions
Conditions
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 23, 2021 (Actual)
- Primary completion
- Jan 15, 2027 (Estimated)
- Completion
- Jan 15, 2027 (Estimated)
- Last update posted
- Jul 28, 2026
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 28, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04644575 live on ClinicalTrials.gov.