Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A
NCT04644575 · View on ClinicalTrials.gov ↗
Study Summary
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 chromogenic FVIII activity assays (only applicable to Arm B). * To evaluate the efficacy of BIVV001 for perioperative management
Conditions Studied
Interventions
- DRUG efanesoctocog alfa (BIVV001)
Study Locations (20)
California
- Orthopaedic Institute for Children Site Number : 8400003 — Los Angeles
- Children's Hospital Los Angeles Site Number : 8400009 — Los Angeles
- University of California San Diego Site Number : 8400007 — San Diego
Michigan
- University of Michigan Medical Center Site Number : 8400006 — Ann Arbor
- Michigan State University School Of Med Site Number : 8400002 — East Lansing
Ohio
- Cincinnati Children's Hospital Medical Center Site Number : 8400012 — Cincinnati
- Children's Research Institute Site Number : 8400013 — Columbus
Florida
- University of Florida Health Site Number : 8400008 — Gainesville
Georgia
- Children's Healthcare of Atlanta Site Number : 8400016 — Atlanta
Illinois
- Rush University Medical Center Site Number : 8400010 — Chicago
Iowa
- Children's Hospital Of Iowa Site Number : 8400011 — Iowa City
Nevada
- Hemostasis and Thrombosis Center of Nevada Site Number : 8400001 — Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2021-02-23 |
| Est. Completion | 2027-01-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04644575
The ClinicalTrials.gov registry entry for NCT04644575 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 261 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bioverativ, a Sanofi company, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention — of which efanesoctocog alfa (BIVV001) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04644575 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Michigan, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04644575 about?
NCT04644575 is a clinical study titled "Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A". 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 BIV...
What is the current status of trial NCT04644575?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 261 participants. The study started on 2021-02-23. Estimated completion is 2027-01-15.
What conditions does trial NCT04644575 study?
This clinical trial studies the following conditions: Hemophilia A. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04644575?
The interventions under investigation include: efanesoctocog alfa (BIVV001) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04644575?
This trial is sponsored by Bioverativ, a Sanofi company, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04644575 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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