A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A
Public ClinicalTrials.gov record NCT04161495. 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 Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients ≥12 Years of Age With Severe Hemophilia A
Study identification
- NCT ID
- NCT04161495
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Bioverativ, a Sanofi company
- Industry
- Enrollment
- 159 participants
Conditions and interventions
Conditions
Interventions
- efanesoctocog alfa (BIVV001) Biological
Biological
Eligibility (public fields only)
- Age range
- 12 Years and older
- 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
- Nov 18, 2019
- Primary completion
- Feb 2, 2022
- Completion
- Feb 2, 2022
- Last update posted
- Sep 16, 2025
2019 – 2022
United States locations
- U.S. sites
- 8
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 920 | Los Angeles | California | 90007-2664 | — |
| Investigational Site Number 921 | Los Angeles | California | 90027 | — |
| Investigational Site Number 911 | San Diego | California | 92121 | — |
| Investigational Site Number 917 | Gainesville | Florida | 32610 | — |
| Investigational Site Number 919 | Ann Arbor | Michigan | 48109 | — |
| Investigational Site Number 908 | Lansing | Michigan | 48824 | — |
| Investigational Site Number 906 | Las Vegas | Nevada | 89113 | — |
| Investigational Site Number 902 | Seattle | Washington | 98101-3932 | — |
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 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04161495, 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 Sep 16, 2025 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04161495 live on ClinicalTrials.gov.