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NCT04759131 · ClinicalTrials.gov registry record · Phase 3
Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A
A Phase 3 study of Hemophilia A, sponsored by Bioverativ, a Sanofi company.
- Completed
- Registry status
- Phase 3
- Development phase
- 74
- Enrollment target
- 20
- Study locations
NCT04759131 is a Phase 3 study of Hemophilia A that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 74 participants, below the 90-participant average among 42 other Hemophilia A trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT04759131, a Phase 3 study of Hemophilia A, has completed, sponsored by Bioverativ, a Sanofi company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 74 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2021-02-19 |
| Est. Completion | 2023-01-18 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 90-participant average among 42 other Hemophilia A trials with a reported enrollment target (18% lower). The listed sponsor is Bioverativ, a Sanofi company, which has 14 total studies on file at ClinicalTrials.gov.
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.
NCT04759131 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Ontario, Other, Ohio.
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.
What interventions are being tested in trial NCT04759131?
The interventions under investigation include: efanesoctocog alfa (BIVV001) (DRUG).
Who is sponsoring clinical trial NCT04759131?
This trial is sponsored by Bioverativ, a Sanofi company, which has 14 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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