A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors

PHASE3CompletedINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

November 18, 2015

Primary Completion Date

October 25, 2016

Study Completion Date

December 1, 2020

Conditions
Hemophilia A
Interventions
DRUG

Emicizumab

Emicizumab will be administered at a loading dose of 3 milligrams per kilogram per week (mg/kg/week) subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. After at least 24 weeks on prophylactic emicizumab, individuals who experience suboptimal bleeding control on emicizumab (according to protocol-defined criteria) will have the opportunity to increase their dose to 3 mg/kg weekly.

DRUG

rFVIIa

Participants will continue to receive rFVIIa.

DRUG

aPCC

Participants will continue to receive aPCC.

Trial Locations (44)

1000

ICIC, San José

1023

Auckland City Hospital; Auckland Haemophilia Centre, Auckland

2050

Royal Prince Alfred Hospital; Haematology, Camperdown

2193

Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center, Johannesburg

3004

The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit, Melbourne

10021

Cornell Univ Medical College; Hematology-Oncolog, New York

10041

National Taiwan Uni Hospital, Taipei

20122

"IRCCS Ca' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi Angelo Bianchi e Bonomi", Milan

20251

CTC North GmbH & Co. KG am Universitätsklinikum Hamburg-Eppendorf, Hamburg

28046

Hospital Universitario la Paz; Servicio de Hematologia, Madrid

30322

Winship Cancer Institute, Atlanta

41013

Hospital Universitario Virgen del Rocio; Servicio de Hematologia, Seville

46026

Hospital Universitario la Fe; Servicio de Hematologia, Valencia

48201

Children's Hospital of Michigan; Pediatrics, Detroit

50134

AOU Careggi; SOD Malattie Emorragiche, Florence

53127

Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin, Bonn

59037

Hopital Cardiologique; Hematologie B, Lille

64546

Hämophilie-Zentrum Rhein Main GmbH, Mörfelden-Walldorf

69677

Hopital Cardio-vasculaire Louis Pradel; Hemostase clinique, Bron

75015

Groupe Hospitalier Necker Enfants Malades, Paris

77030

Univ of TX Health Science Ctr; Gulf States Hemo and Throm Ctr, Houston

80045

University of Colorado Denver, Children's Hospital, Aurora

90010

Children's Hospital Los Angeles, Los Angeles

90403

Santa Monica Oncology Center, Santa Monica

94275

CH de Bicetre; Centre de Traitement d' Hemophilie, Le Kremlin-Bicêtre

97201

Oregon Health & Science Uni ; Dept of Pediatrics, Portland

98104

Bloodworks Northwest (formerly Puget Sound Blood Center); Hemophilia, Seattle

02115

Boston Childrens Hospital, Boston

17033-0850

Pennsylvania State Hershey Medical Center; Division of Hematology/Oncology, H046, Hershey

466-8560

Nagoya University Hospital, Aichi

734-8551

Hiroshima University Hospital, Hiroshima

663-8501

Hyogo College of Medicine Hospital, Hyōgo

216-8511

St. Marianna University School of Medicine Hospital, Kanagawa

807-8556

Hospital of the University of Occupational and Environmental Health,Japan, Kitakyushu-shi

634-8522

Nara Medical University Hospital, Nara

160-0023

Tokyo Medical University Hospital, Tokyo

80-952

Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii, Gdansk

20-081

SPSK Nr1 Klinika Hematoo&Transpl.Szpiku, Lublin

60-549

ALVAMED Lekarskie Gabinety Specjalistyczne, Poznan

02-776

Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych, Warsaw

03722

Severance Hospital, Seoul

CF14 4XW

Cardiff and Vale NHS Trust, Cardiff

SE1 7EH

St Thomas' Hospital; Haemostasis & Thromboisis Centre, London

OX3 7LE

Oxford University Hospitals NHS Trust - Churchill Hospital, Oxford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Chugai Pharmaceutical

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY