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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: Completed Phase 3 study, sponsored by Bioverativ, a Sanofi company.
NCT04161495 is a Phase 3 study that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 159 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ABR is annualized number of treated bleeding episodes (BE) per participant per year. Treated Bleeding episode: any occurrence of hemorrhage that required administration of BIVV001. It started from 1st sign of bleed and ended no more than 72 hours after last injection to treat bleeding episode, any subsequent bleeding at same location/injections administered less than or equal to (\<=) 72 hours apart from previous injection were considered same bleeding episode. ABR=number of treated BE during ef
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 |
What the finished NCT04161495 record still lists
NCT04161495 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which efanesoctocog alfa (BIVV001) is the first listed.
NCT04161495 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04161495's enrollment target sits among peer trials
159 1501st of 2000 higher than 499 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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