Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A

NCT04759131 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG efanesoctocog alfa (BIVV001)

Study Locations (20)

Ontario

  • Investigational Site Number :1240004 — Hamilton
  • Investigational Site Number :1240003 — London
  • Investigational Site Number :1240002 — Ottawa
  • Investigational Site Number :1240001 — Toronto

Other

  • Investigational Site Number :2500004 — Bron
  • Investigational Site Number :2500001 — Le Kremlin-Bicêtre
  • Investigational Site Number :2500003 — Lille
  • Investigational Site Number :2760001 — Frankfurt am Main

Ohio

  • Cincinnati Children's Hospital Medical Center-Site Number:8400008 — Cincinnati
  • Childrens Hospital Of Columbus-Site Number:8400012 — Columbus

California

  • Children's Hospital Los Angeles-Site Number:8400006 — Los Angeles

Florida

  • University of Florida-Site Number:8400009 — Gainesville

Georgia

  • Children's Healthcare of Atlanta-Site Number:8400019 — Atlanta

Illinois

  • Rush University Medical Center-Site Number:8400001 — Chicago

Iowa

  • University of Iowa Hospitals and Clinics-Site Number:8400002 — Iowa City

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2021-02-19
Est. Completion 2023-01-18
Phase Phase 3

Sponsor

Bioverativ, a Sanofi company

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04759131

The ClinicalTrials.gov registry entry for NCT04759131 describes a study currently listed as completed. 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 74 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: NCT04759131 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Ontario, Other, 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 NCT04759131 about?

NCT04759131 is a clinical study titled "Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A". 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 evaluat...

What is the current status of trial NCT04759131?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 74 participants. The study started on 2021-02-19. Estimated completion is 2023-01-18.

What conditions does trial NCT04759131 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 NCT04759131?

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 NCT04759131?

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 NCT04759131 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial