A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors

PHASE3CompletedINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

September 5, 2017

Primary Completion Date

November 19, 2020

Study Completion Date

November 19, 2020

Conditions
Hemophilia A
Interventions
DRUG

Emicizumab

Initial dosing will be 3 mg/kg/week subcutaneously for 4 weeks; Maintenance dosing will follow at 1.5 mg/kg/week subcutaneously for the remainder of the 2-year treatment period

Trial Locations (72)

1134

Magyar Honvédség Egészségügyi Központ; Országos Haemophilia Központ, Budapest

2050

Royal Prince Alfred Hospital; Haematology, Camperdown

3000

UZ Leuven Gasthuisberg, Leuven

3004

Alfred Hospital, Melbourne

3010

Inselspital Bern; Hämatologie und Hämatologisches Zentrallabor, Bern

6150

Fiona Stanley Hospital, Murdoch

7624

University of Pecs, I st Dept of Internal Medicine, Pécs

9023

Országos Vérellátó Szolgálat - Győri Regionális Vérellátó Központ, Győr

10126

AO Città Salute e Scienza D-Osp S. G. Battista Molinette; SSCVD Malattie Tromboti e Emorragiche, Turin

10249

Vivantes Klinikum im Friedrichshain - Landsberger Allee, Angiologie und Hämostaseologie, Berlin

11211

King Faisal Specialist Hospital & Research Centre; Oncology, Riyadh

20122

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

28046

Hospital Universitario la Paz; Servicio de Hematologia, Madrid

29010

Hospital Regional Universitario Carlos Haya; Servicio de Hematologia, Málaga

35128

Azienda Ospedaliera di Padova; Centro Emofilia, Padua

40138

AOU Policlinico S. Orsola Malpighi; U.O. Angiologia e Malattie della Coagulazione Marino Golinelli, Bologna

41013

Hospital Universitario Virgen del Rocio; Servicio de Hematologia, Seville

43126

AOU di Parma; Dip Emergenza-Urgenza Centro Riferimento Regionale per l'emofilia, Parma

46026

Hospital Universitario la Fe; Servicio de Hematologia, Valencia

50134

AOU Careggi; SOD Malattie Emorragiche, Florence

53127

Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin, Bonn

60590

Hämophiliezentrum Med. Klinik III/Institut für Transfusionsmedizin; Johann Wolfgang Goethe-Univers., Frankfurt/M.

64546

Hämophilie-Zentrum Rhein Main GmbH, Mörfelden-Walldorf

80131

AOU Federico II; Medicina Clinica Chirurgia Centro Emocoaugulopatie e Emofilia, Napoli

80336

Klinikum der Universität München, Campus Innenstadt; Hämostaseologische Ambulanz/Hämophiliezentrum, München

90127

Azienda Uni Ria Policlinico P. Giaccone ; Divisione Di Ematologia E Trapianto, Palermo

111611

Centro de Atención e Investigación Médica CAIMED S.A.S, Localidad Puente Aranda

119049

Morozov Children's Municipal Clinical Hospital. Haematology department, Moscow

125167

"Hematological Scientific Center", Moscow

191186

City Outpatient Clinic #37, City Hemophilia Treatment Center, Saint Petersburg

300011

Louis Turcanu Emergency Clinical Hospital for Children; First Pediatric Clinic, Timișoara

400012

King Edward Memorial Hospital and Seth G.S. Medical College; Department of Hematology, Mumbai

400078

Fortis Hospitals Limited, Mumbai

411001

Grant Medical Foundation, Ruby Hall Clinic, Pune

411004

Sahyadri Speciality Hospital; Hematology & Bone Marrow Unit, Pune

443099

Samara State Medical University, Samara

560034

St. John's Medical College & Hospital; Department of Medicine, Bengaluru

632004

Christian Medical College & Hospital; Department of Haematology, Vellore

656024

"Regional State Budgetary Institution of Healthcare Regional Cinilcal Hospital; Pulmonology", Barnaul

700014

Nil Ratan Sircar Medical College and Hospital; Department of Hematology, Kolkata

5262100

Sheba Medical Center - National Hemophilia Center, Tel Litwinsky

80045-145

Centro de Hematologia E Hemoterapia Do Parana - Hemepar, Curitiba

20211-030

Instituto Estadual de Hema, Rio de Janeiro

13083-888

Hospital das Clinicas - UNICAMP, Campinas

14051-140

Faculdade de Medicina de Ribeirão Preto - Universidade de Sao Paulo, Ribeirão Preto

T6G 2V2

Kaye Edmonton Clinic, Edmonton

R2H 2A6

CancerCare Manitoba; Neuro-Oncology, Winnipeg

L8N 3Z5

McMaster University Health Sciences Center, Hamilton

M5B 1W8

St. Michael's Hospital, Toronto

050034

Hospital Pablo Tobon Uribe, Medellín

00290

Helsingin yliopistollinen keskussairaala, Meilahden sairaala, Helsinki

04103

Universitätsklinikum Leipzig, Innere Medizin, Neurologie, Dermatologie; Zentrum für Hämostaseologie, Leipzig

01010

Oncomedica, Guatemala City

00161

Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol, Rome

06726

Hospital General de México, Distrito Federal

06720

CENTRO MEDICO NACIONAL SIGLO XXI; Banco de Sangre, Mexico City

02990

Hospital de Especialidades Centro Medico Nacional La Raza; Haematology, Mexico City

3015 GJ

Erasmus MC / location Sophia Kinderziekenhuis, Rotterdam

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

0824

Complejo Hospitalario Arnulfo Arias Madrid; Servicio de Hematología, Panama City

02-776

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

3041-853

Hospital Geral; Servico de Imuno-Hemoterapia, Coimbra

1649-035

Hospital de Santa Maria; Servico de Imuno-Hemoterapia; Servico de Imuno-Hemoterapia, Lisbon

4200-319

Hospital de Sao Joao; Servico de Imuno-Hemoterapia; Servico de Imuno-Hemoterapia, Porto

08035

Hospital Universitario Vall de Hebron; Unidad de Hemofília, Barcelona

413 45

Sahlgrenska Universitetssjukhuset; Koagulationscentrum, Gothenburg

171 64

Karolinska Universitetssjukhuset; Koagulationsmottagningen, Solna

B15 2TH

University Hospitals Birmingham NHS Foundation Trust, Birmingham

E1 2ES

The Royal London Hospital, London

NW3 2QS

Royal Free Hospital, London

NE1 4LP

Royal Victoria Infirmary; Non-Malignant Haematology Research, Newcastle upon Tyne

S10 2JF

Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03191799 - A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors | Biotech Hunter | Biotech Hunter