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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

261

Participants

Timeline

Start Date

February 23, 2021

Primary Completion Date

January 15, 2027

Study Completion Date

January 15, 2027

Conditions
Hemophilia A
Interventions
DRUG

efanesoctocog alfa (BIVV001)

Pharmaceutical form:Solution for Injection Route of administration: Intravenous

Trial Locations (85)

407

Investigational Site Number : 1580003, Taichung

500

Investigational Site Number : 1580005, Changhua County

1134

Investigational Site Number : 3480002, Budapest

1200

Investigational Site Number : 0560003, Woluwe-Saint-Lambert

1756

Investigational Site Number : 1000172, Sofia

2050

Investigational Site Number : 0360004, Camperdown

2145

Investigational Site Number : 0360001, Westmead

4002

Investigational Site Number : 1000171, Plovdiv

4093

Investigational Site Number : 3480004, Debrecen

4101

Investigational Site Number : 0360002, South Brisbane

6961

Investigational Site Number : 0360003, Murdoch

7623

Investigational Site Number : 3480005, Pécs

8032

Investigational Site Number : 7560001, Zurich

10002

Investigational Site Number : 1580002, Taipei

10021

New York Presbyterian Hospital/Weill Cornell Medical Center Site Number : 8400017, New York

10249

Investigational Site Number : 2760304, Berlin

11031

Investigational Site Number : 1580004, Taipei

11527

Investigational Site Number : 3000001, Athens

13385

Investigational Site Number : 2500006, Marseille

20121

Investigational Site Number : 3800001, Milan

20502

Investigational Site Number : 7520001, Malmo

27834

East Carolina University -2390 Hemby Ln Site Number : 8400015, Greenville

28046

Investigational Site Number : 7240001, Madrid

29200

Investigational Site Number : 2500005, Brest

30322

Children's Healthcare of Atlanta Site Number : 8400016, Atlanta

32608

University of Florida Health Site Number : 8400008, Gainesville

34390

Investigational Site Number : 7920001, Istanbul

36100

Investigational Site Number : 3800003, Vicenza

40201

Investigational Site Number : 1580001, Taichung

41404

Investigational Site Number : 4100603, Daegu

45229

Cincinnati Children's Hospital Medical Center Site Number : 8400012, Cincinnati

48109

University of Michigan Medical Center Site Number : 8400006, Ann Arbor

48824

Michigan State University School Of Med Site Number : 8400002, East Lansing

52242

Children's Hospital Of Iowa Site Number : 8400011, Iowa City

53127

Investigational Site Number : 2760302, Bonn

59037

Investigational Site Number : 2500003, Lille

60590

Investigational Site Number : 2760001, Frankfurt am Main

69500

Investigational Site Number : 2500004, Bron

80123

Investigational Site Number : 3800002, Napoli

80337

Investigational Site Number : 2760002, München

89113

Hemostasis and Thrombosis Center of Nevada Site Number : 8400001, Las Vegas

90007

Orthopaedic Institute for Children Site Number : 8400003, Los Angeles

90027

Children's Hospital Los Angeles Site Number : 8400009, Los Angeles

92121

University of California San Diego Site Number : 8400007, San Diego

94275

Investigational Site Number : 2500001, Le Kremlin-Bicêtre

98104

Bloodworks Northwest Site Number : 8400005, Seattle

100045

Investigational Site Number : 1560002, Beijing

100730

Investigational Site Number : 1560006, Beijing

215006

Investigational Site Number : 1560007, Suzhou

250013

Investigational Site Number : 1560005, Jinan

310003

Investigational Site Number : 1560003, Hangzhou

Investigational Site Number : 1560004, Hangzhou

510515

Investigational Site Number : 1560001, Guangzhou

650032

Investigational Site Number : 1560009, Kunming

650101

Investigational Site Number : 1560010, Kunming

730000

Investigational Site Number : 1560013, Lanzhou

60612-3833

Rush University Medical Center Site Number : 8400010, Chicago

43205-2696

Children's Research Institute Site Number : 8400013, Columbus

53226-0509

Children's Hospital of Wisconsin Site Number : 8400014, Milwaukee

C1425BWE

Investigational Site Number : 0320001, CABA

M5504FKD

Investigational Site Number : 0320002, Godoy Cruz

C1015ABO

Investigational Site Number : 0320003, Buenos Aires

13083-970

Hemocentro Campinas - UNICAMP Site Number : 0760001, Campinas

L8L 8E7

Investigational Site Number : 1240005, Hamilton

L8N 3Z5

Investigational Site Number : 1240004, Hamilton

K1H 8L1

Investigational Site Number : 1240002, Ottawa

M5G 1X8

Investigational Site Number : 1240001, Toronto

D12 N512

Investigational Site Number : 3720001, Dublin

466-0065

Investigational Site Number : 3920425, Nagoya

807-8556

Investigational Site Number : 3920423, Kitakyushu-shi

216-8511

Investigational Site Number : 3920426, Kawasaki-shi

634-8521

Investigational Site Number : 3920422, Kashihara-Shi

160-0023

Investigational Site Number : 3920421, Shinjuku-ku

167-0035

Investigational Site Number : 3920424, Suginami-ku

1105 AZ

Investigational Site Number : 5280002, Amsterdam

3584 CX

Investigational Site Number : 5280001, Utrecht

03722

Investigational Site Number : 4100601, Seoul

05278

Investigational Site Number : 4100600, Seoul

08950

Investigational Site Number : 7240002, Esplugues de Llobregat

07059

Investigational Site Number : 7920004, Antalya

TR-35100

Investigational Site Number : 7920003, Izmir

NW3 2QG

Investigational Site Number : 8260005, London

WC1N 3JH

Investigational Site Number : 8260001, London

B4 6NH

Investigational Site Number : 8260003, Birmingham

RG24 9NA

Investigational Site Number : 8260004, Hampshire

All Listed Sponsors
lead

Bioverativ, a Sanofi company

INDUSTRY