Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A
Active, not recruiting · Phase 3 · NCT04644575
Conditions: Hemophilia A
At a glance
- Research payments reported, 2025
- $58,115
- U.S. investigators named
- 8
- Sites paid
- 8
- Planned or actual enrollment
- 261
About the trial
- Sponsor
- Bioverativ, a Sanofi company
- Tested
- efanesoctocog alfa (BIVV001) (drug)
- Dates
- Started 2021-02-23; completion 2027-01-15
- Results posted
- Not yet
Primary Objective: \- To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia A 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 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 (QoL) outcomes. * To evaluate the safety and tolerability of BIVV001 treatment. * To assess the PK of BIVV001 based on the one stage activated partial thromboplastin time (aPTT) and two-stage…
From ClinicalTrials.gov, last updated 2026-07-28. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $58,115 in research payments for this study in 2025 (10 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.
U.S. investigators named on this study
- Annette Von Drygalski, MD Hematology & Oncology · San Diego, CA
- Guy A. Young, M.D. Pediatric Hematology & Oncology · Los Angeles, CA
- Tung T. Wynn, M.D. Pediatric Hematology & Oncology · Gainesville, FL
- Mindy L. Simpson, M.D. Pediatric Hematology & Oncology · Chicago, IL
- Roshni Kulkarni, M.D. Pediatric Hematology & Oncology · Lansing, MI
- Angela C. Weyand, M.D. Pediatric Hematology & Oncology · Ann Arbor, MI
- Amy L. Dunn, MD Pediatric Hematology & Oncology · Columbus, OH
- Barbara A. Konkle, MD Hematology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- University of Florida Contracts Grants $14,625
- Washington Institute for Coagulation Washington Center for Bleeding Disorders $10,000
- University of California San Diegodispersements $7,735
- University of Michigan Health System, MI $7,500
- The Research Institute at Nationwid Childrens Hospital Abigail Wexner Research Institute A Nationwid $7,159
- Michigan State University Center for Bleeding and Cloting Dis $6,409
- Rush University Medical Center, IL $3,094
- Children's Hosp of Los Angeles, CA $1,594
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.