Clinical trial
Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously…
NCT04644575 · Bioverativ, a Sanofi company, Industry · Active, not recruiting
Key facts
| NCT number | NCT04644575 |
|---|---|
| Title | Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A |
| 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 |
| Acronym | XTEND-ed |
| Lead sponsor | Bioverativ, a Sanofi company, Industry |
| Status | Active, not recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Hemophilia A |
| Intervention type | Drug |
| Interventions | efanesoctocog alfa (BIVV001) |
| Enrollment | 261 |
| Start date | Feb 23, 2021 |
| Primary completion | Jan 15, 2027 |
| Completion | Jan 15, 2027 |
| First posted | Nov 25, 2020 |
| Last update posted | Aug 1, 2025 |
| Countries | Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, France, Germany, Greece, Hungary, Ireland and 11 more |
At a glance
- 100–999 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: