Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A
Public ClinicalTrials.gov record NCT04759131. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Open-label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Pediatric Patients <12 Years of Age With Severe Hemophilia A
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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) of BIVV001.
Study identification
- NCT ID
- NCT04759131
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 74 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 11 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 19, 2021 (Actual)
- Primary completion
- Jan 18, 2023 (Actual)
- Completion
- Jan 18, 2023 (Actual)
- Last update posted
- Sep 11, 2025
2021 – 2023
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles-Site Number:8400006 | Los Angeles | California | 90027 | — |
| University of Florida-Site Number:8400009 | Gainesville | Florida | 32610 | — |
| Children's Healthcare of Atlanta-Site Number:8400019 | Atlanta | Georgia | 30322 | — |
| Rush University Medical Center-Site Number:8400001 | Chicago | Illinois | 60612-3833 | — |
| University of Iowa Hospitals and Clinics-Site Number:8400002 | Iowa City | Iowa | 52242 | — |
| NY Presbyterian - Weill Cornell Medical Center-Site Number:8400020 | New York | New York | 10021 | — |
| East Carolina University/Brody Medical Sciences Building-Site Number:8400015 | Greenville | North Carolina | 27834 | — |
| Cincinnati Children's Hospital Medical Center-Site Number:8400008 | Cincinnati | Ohio | 45206 | — |
| Childrens Hospital Of Columbus-Site Number:8400012 | Columbus | Ohio | 43205 | — |
| Children's Hospital Of Wisconsin-Site Number:8400005 | Milwaukee | Wisconsin | 53226-0509 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04759131, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 11, 2025 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04759131 live on ClinicalTrials.gov.