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efanesoctocog alfa (BIVV001)

DRUG4 trials

Sponsors

Bioverativ, a Sanofi company

Conditions

Factor VIII DeficiencyHemophilia AVon Willebrand's Disease (VWD)

Phase 1

To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)
CompletedNCT04770935
Bioverativ, a Sanofi companyVon Willebrand's Disease (VWD)
Start: 2021-05-03End: 2022-12-20Updated: 2025-09-25

Phase 3

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
CompletedNCT04161495
Bioverativ, a Sanofi companyFactor VIII Deficiency
Start: 2019-11-19End: 2022-02-03Updated: 2025-09-17
Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A
Active, not recruitingNCT04644575
Bioverativ, a Sanofi companyHemophilia A
Start: 2021-02-23End: 2027-01-15Updated: 2026-07-28
Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A
CompletedNCT04759131
Bioverativ, a Sanofi companyHemophilia A
Start: 2021-02-19End: 2023-01-18Updated: 2025-09-11

Related Papers

A Psychometric Analysis of the Haemophilia Quality of Life Questionnaire for Adults Physical Health Subscale and Total Scores: Data From the Phase 3 XTEND-1 Trial in Patients With Severe Haemophilia A.
2026-03-06
Outcomes in participants switching from FVIII replacement therapy to efanesoctocog alfa prophylaxis in XTEND-1: a post hoc analysis.
2026-01-20
Clinical outcomes up to 4 years of once-weekly efanesoctocog alfa prophylaxis in previously treated adults, adolescents, and children with severe hemophilia A: Interim analysis of the Phase 3 XTEND-ed long-term extension study
Blood2025-11-03
Real-world experience of efanesoctocog alfa in Hemophilia A patients in the US: A retrospective analysis
Blood2025-11-03
Post hoc analysis of bleeding episodes and clinically relevant pharmacokinetic parameters among children <12 years old with severe hemophilia A receiving once-weekly efanesoctocog alfa prophylaxis in the XTEND-Kids phase 3 multinational trial.
2025-07-21
A phase 1, open-label study to assess the pharmacokinetics, safety, and tolerability of a single intravenous injection of efanesoctocog alfa in adults with type 2N or type 3 von Willebrand disease.
2025-07-18
Efanesoctocog Alfa Population Pharmacokinetics and Repeated Time‐To‐Event Analysis of Bleeds in Adults, Adolescents, and Children with Severe Hemophilia A
The Journal of Clinical Pharmacology2025-03-231 citations
Perioperative Management With Efanesoctocog Alfa in Patients With Haemophilia A in the Phase 3 XTEND‐1 and XTEND‐Kids Studies
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Treatment of Bleeding Episodes With Efanesoctocog Alfa in Previously Treated Patients With Severe Hemophilia A in the Phase 3 <scp>XTEND</scp>‐1 Study
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High-Fidelity Clinical Simulation to Improve a Pediatric Clinical Trial Design: Lessons Learned and Conceptualization of the Return on Investment (ROI) and Return on Engagement (ROE) Analysis.
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Efanesoctocog Alfa versus Standard and Extended Half-Life Factor VIII Prophylaxis in Adolescent and Adult Patients with Haemophilia A without Inhibitors.
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Efanesoctocog Alfa Versus Emicizumab in Adolescent and Adult Patients With Haemophilia A Without Inhibitors.
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Association between Hemophilia Joint Health Score and Quality of Life Using Results from the Xtend-1 Efanesoctocog Alfa Phase 3 Trial
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Cost Comparison of Efanesoctocog Alfa with Existing Factor VIII Replacement Therapies for Major Surgeries in People with Severe Hemophilia a
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Strategies for Increasing Racial and Ethnic Diversity in Hemophilia Clinical Trials and Their Outcomes
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Efanesoctocog Alfa Prophylaxis for Children with Severe Hemophilia A
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10 more papers not shown