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
Completed · Phase 3 · NCT04161495
Conditions: Factor VIII Deficiency
At a glance
- Research payments reported, 2025
- $4,500
- U.S. investigators named
- 0
- Sites paid
- 0
- Planned or actual enrollment
- 159
About the trial
- Sponsor
- Bioverativ, a Sanofi company
- Tested
- efanesoctocog alfa (BIVV001) (biological)
- Dates
- Started 2019-11-19; completion 2022-02-03
- Results posted
- Yes
Primary Objective: \- To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm. 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 the 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 outcomes. * To evaluate the efficacy of BIVV001 for perioperative management. * To evaluate the safety and tolerability of BIVV001 treatment. * To assess the pharmacokinetics (PK) of BIVV…
From ClinicalTrials.gov, last updated 2025-09-17. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Genzyme Corporation reported $4,500 in research payments for this study in 2025 (12 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
Sites paid to run it
- $4,500
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.