Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A
Completed · Phase 3 · NCT04759131
Conditions: Hemophilia A
At a glance
- Research payments reported, 2025
- $1,500
- U.S. investigators named
- 0
- Sites paid
- 0
- Planned or actual enrollment
- 74
About the trial
- Sponsor
- Bioverativ, a Sanofi company
- Tested
- efanesoctocog alfa (BIVV001) (drug)
- Dates
- Started 2021-02-19; completion 2023-01-18
- Results posted
- Yes
Primary Objective: \- To evaluate the safety of BIVV001 in previously treated pediatric participants 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 efficacy of BIVV001 for perioperative management. * To evaluate the safety and tolerability of BIVV001 treatment. * To assess the pharmacokinetics (PK) …
From ClinicalTrials.gov, last updated 2025-09-11. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Genzyme Corporation reported $1,500 in research payments for this study in 2025 (4 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
- $1,500
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.