# 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

> **NCT04161495** · PHASE3 · COMPLETED · sponsor: **Bioverativ, a Sanofi company** · enrollment: 159 (actual)

## Conditions studied

- Factor VIII Deficiency

## Interventions

- **BIOLOGICAL:** efanesoctocog alfa (BIVV001)

## Key facts

- **NCT ID:** NCT04161495
- **Lead sponsor:** Bioverativ, a Sanofi company
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-11-19
- **Primary completion:** 2022-02-03
- **Final completion:** 2022-02-03
- **Target enrollment:** 159 (ACTUAL)
- **Last updated:** 2025-09-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04161495

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04161495, "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". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT04161495. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*