7 completed, 3 active not recruiting, 1 recruiting. 5 Phase 3, 4 Phase 1, 1 Phase 2, 1 Phase 4.
By phase and status
Follow BIVV001: new trials by email Literature Review of BIVV001 trials Research Report on BIVV001
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy
Efanesoctocog alfa - Factor VIII Deficiency | Phase 4 | Recruiting | Sanofi | 35 | 2025-09-23 | 2026-10-15 |
Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa
Efanesoctocog alfa - Haemophilia A (Moderate or Severe) | Phase 3 | Active not recruiting | Swedish Orphan Biovitrum | 89 | 2025-03-06 | 2026-10-19 |
Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A
Efanesoctocog alfa - Hemophilia A | Phase 1 | Completed | Swedish Orphan Biovitrum | 24 | 2025-02-24 | 2026-06-25 |
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan
Efanesoctocog alfa - Hemophilia A | | Active not recruiting | Sanofi | 79 | 2024-11-11 | 2026-09-25 |
A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa
Efanesoctocog alfa - Hemophilia A, Severe | Phase 3 | Completed | Swedish Orphan Biovitrum | 93 | 2023-07-31 | 2026-07-02 |
Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A
Efanesoctocog alfa, Octocog alfa, Rurioctocog alfa pegol - Hemophilia A | Phase 1 | Completed | Sanofi | 13 | 2021-08-11 | 2025-09-18 |
To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)
efanesoctocog alfa (BIVV001) - Von Willebrand's Disease (VWD) | Phase 1 | Completed | Bioverativ, a Sanofi company | 6 | 2021-05-03 | 2025-09-25 |
Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A
efanesoctocog alfa (BIVV001) - Hemophilia A | Phase 3 | Active not recruiting | Bioverativ, a Sanofi company | 261 | 2021-02-23 | 2026-07-28 |
Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A
efanesoctocog alfa (BIVV001) - Hemophilia A | Phase 3 | Completed | Bioverativ, a Sanofi company | 74 | 2021-02-19 | 2025-09-11 |
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
efanesoctocog alfa (BIVV001) - Factor VIII Deficiency | Phase 3 | Completed | Bioverativ, a Sanofi company | 159 | 2019-11-19 | 2025-09-17 |
A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A)
Advate (Low Dose), Advate (High Dose), BIVV001 (Low Dose) - Hemophilia A | Phase 1 / Phase 2 | Completed | Bioverativ, a Sanofi company | 16 | 2017-08-28 | 2022-04-19 |
Conditions studied
Hemophilia A (10) · Coagulation Protein Disorders (4) · Blood Coagulation Disorders (3) · Blood Coagulation Disorders, Inherited (1) · Genetic Diseases, Inborn (1) · Hemarthrosis (1) · Hematologic Diseases (1) · Hemorrhagic Disorders (1) · Lymphoma, Follicular (1) · von Willebrand Diseases (1)
Sponsors
Bioverativ, a Sanofi company (5) · Sanofi (3) · Swedish Orphan Biovitrum (3)
Countries
France (6) · Italy (6) · Spain (6) · United States (6) · Bulgaria (5) · Germany (5) · Taiwan (5) · Canada (4) · Greece (4) · Japan (4) · Netherlands (4) · Sweden (4) · United Kingdom (4) · Australia (3) · Hungary (3)
Top investigators
Elena Santagostino, MD (1)
Results publications
PMID 40099428, PMID 32905674, PMID 36720133, PMID 37538505, PMID 39018533, PMID 39414418, PMID 39576432, PMID 39576433, PMID 39585605, PMID 39927501, PMID 40701256, PMID 41583536, PMID 41789959, PMID 42598540, PMID 42786406
NIH funding
2023 (2), 2019 (1)