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NCT04161495 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A
A Phase 3 study, sponsored by Bioverativ, a Sanofi company.
- Completed
- Registry status
- Phase 3
- Development phase
- 159
- Enrollment target
NCT04161495 is a Phase 3 study that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 159 participants.
The verdict
NCT04161495, a Phase 3 study, has completed, sponsored by Bioverativ, a Sanofi company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 159 participants
- Enrollment target
Study Summary
Primary Objective: \- To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm. 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 the 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 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 based on the 1-stage activated partial thromboplastin time (aPTT) and 2-stage chromogenic coagulation factor VIII (FVIII) activity assays.
Interventions
- BIOLOGICAL efanesoctocog alfa (BIVV001)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2019-11-19 |
| Est. Completion | 2022-02-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04161495
The ClinicalTrials.gov registry entry for NCT04161495 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 159 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 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which efanesoctocog alfa (BIVV001) is the first listed.
NCT04161495 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04161495 about?
NCT04161495 is a clinical study titled "A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A". Primary Objective: \- To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm. 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 NCT04161495?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 159 participants. The study started on 2019-11-19. Estimated completion is 2022-02-03.
What interventions are being tested in trial NCT04161495?
The interventions under investigation include: efanesoctocog alfa (BIVV001) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04161495?
This trial is sponsored by Bioverativ, a Sanofi company, which has 14 total clinical trials registered on ClinicalTrials.gov.
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