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

PHASE3CompletedINTERVENTIONAL
Enrollment

159

Participants

Timeline

Start Date

November 19, 2019

Primary Completion Date

February 3, 2022

Study Completion Date

February 3, 2022

Conditions
Factor VIII Deficiency
Interventions
BIOLOGICAL

efanesoctocog alfa (BIVV001)

Pharmaceutical form: solution for injection Route of administration: IV injection

Trial Locations (47)

32610

Investigational Site Number 917, Gainesville

48109

Investigational Site Number 919, Ann Arbor

48824

Investigational Site Number 908, Lansing

89113

Investigational Site Number 906, Las Vegas

90027

Investigational Site Number 921, Los Angeles

92121

Investigational Site Number 911, San Diego

90007-2664

Investigational Site Number 920, Los Angeles

98101-3932

Investigational Site Number 902, Seattle

Unknown

Investigational Site Number 136, Buenos Aires

Investigational Site Number 137, Buenos Aires

Investigational Site Number 139, Mendoza

Investigational Site Number 121, Perth

Investigational Site Number 122, Sydney

Investigational Site Number 161, Brussels

Investigational Site Number 181, Campinas

Investigational Site Number 171, Plovdiv

Investigational Site Number 172, Sofia

Investigational Site Number 202, Hamilton

Investigational Site Number 205, Hamilton

Investigational Site Number 281, Brest

Investigational Site Number 283, Lille

Investigational Site Number 282, Lyon

Investigational Site Number 284, Marseille

Investigational Site Number 304, Berlin

Investigational Site Number 302, Bonn

Investigational Site Number 303, Frankfurt

Investigational Site Number 321, Athens

Investigational Site Number 312, Budapest

Investigational Site Number 314, Debrecen

Investigational Site Number 402, Milan

Investigational Site Number 401, Vicenza

Investigational Site Number 426, Kawasaki

Investigational Site Number 423, Kitakyushu

Investigational Site Number 425, Nagoya

Investigational Site Number 422, Nara

Investigational Site Number 421, Tokyo

Investigational Site Number 424, Tokyo

Investigational Site Number 435, Durango

Investigational Site Number 641, Utrecht

Investigational Site Number 603, Daegu

Investigational Site Number 600, Seoul

Investigational Site Number 601, Seoul

Investigational Site Number 521, Madrid

Investigational Site Number 531, Chang-hua

Investigational Site Number 532, Taipei

Investigational Site Number 581, Basingstoke

Investigational Site Number 581, London

All Listed Sponsors
lead

Bioverativ, a Sanofi company

INDUSTRY

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 | Biotech Hunter | Biotech Hunter