Active Not Recruiting PHASE3 INTERVENTIONAL 3-arm NCT04644575

Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A (XTEND-ed)

A Phase 3 Open-label, Multicenter Study of the Long-term Safety and Efficacy of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients With Severe Hemophilia A

Sponsor: Bioverativ, a Sanofi company

Conditions Hemophilia A

Interventions efanesoctocog alfa (BIVV001)

Updated 21 times since 2020 Last updated: Jul 31, 2025 Started: Feb 23, 2021 Primary completion: Jan 15, 2027 Completion: Jan 15, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04644575, this PHASE3 trial focuses on Hemophilia A and remains ongoing. Sponsored by Bioverativ, a Sanofi company, it has been updated 21 times since 2021, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

21 versions recorded

Sep 2025 — Present [monthly]

Active Not Recruiting PHASE3
Sep 2024 — Sep 2025 [monthly]

Active Not Recruiting PHASE3
Jul 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE3
Apr 2024 — Jul 2024 [monthly]

Active Not Recruiting PHASE3
Nov 2023 — Apr 2024 [monthly]

Active Not Recruiting PHASE3

▶ Show 16 earlier versions

Apr 2023 — Nov 2023 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Feb 2023 — Apr 2023 [monthly]

Recruiting PHASE3
Nov 2022 — Feb 2023 [monthly]

Recruiting PHASE3
Sep 2022 — Nov 2022 [monthly]

Recruiting PHASE3
Jun 2022 — Sep 2022 [monthly]

Recruiting PHASE3
Apr 2022 — Jun 2022 [monthly]

Recruiting PHASE3
Mar 2022 — Apr 2022 [monthly]

Recruiting PHASE3
Feb 2022 — Mar 2022 [monthly]

Recruiting PHASE3
Jan 2022 — Feb 2022 [monthly]

Recruiting PHASE3
Dec 2021 — Jan 2022 [monthly]

Recruiting PHASE3
May 2021 — Dec 2021 [monthly]

Recruiting PHASE3
Apr 2021 — May 2021 [monthly]

Recruiting PHASE3
Mar 2021 — Apr 2021 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Feb 2021 — Mar 2021 [monthly]

Not Yet Recruiting PHASE3
Jan 2021 — Feb 2021 [monthly]

Not Yet Recruiting PHASE3
Dec 2020 — Jan 2021 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Bioverativ, a Sanofi company

Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Amsterdam, Netherlands , Ann Arbor, United States , Antalya, Turkey (Türkiye) , Athens, Greece , Atlanta, United States , Beijing, China , Berlin, Germany , Birmingham, United Kingdom , Bonn, Germany , Brest, France and 66 more locations