A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%)

PHASE3CompletedINTERVENTIONAL
Enrollment

213

Participants

Timeline

Start Date

July 26, 2018

Primary Completion Date

December 13, 2024

Study Completion Date

December 13, 2024

Conditions
Hemophilia BHemophilia A
Interventions
DRUG

Standard of Care FIX Replacement therapy

There is no investigational product being administered. Subjects will be administering their own standard of care FIX replacement therapy.

DRUG

Standard of Care FVIII Replacement therapy

There is no investigational product being administered. Subjects will be administering their own standard of care FVIII replacement therapy.

Trial Locations (75)

500

Changhua Christian Hospital, Changhua

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1200

Cliniques universitaires Saint-Luc/Unité d'Hématology et Hémostase, Brussels

2050

Royal Prince Alfred Hospital, Camperdown

3004

The Alfred Hospital, Melbourne

4029

Royal Brisbane and Women's Hospital, Herston

5000

Royal Adelaide Hospital, Adelaide

6150

Fiona Stanley Hospital, Murdoch

10002

National Taiwan University Hospital, Taipei

10249

Vivantes Klinikum Friedrichshain, Berlin

11426

King Abdulaziz Medical City, Riyadh

11527

"General Hospital of Athens Hippokration", Athens

"General Hospital of Athens LAIKO, 2nd Regional Blood Transfusion Center", Athens

19104

Penn Blood Disorder Center, Philadelphia

27310

Gaziantep University Sahinbey Training and Research Hospital, Gaziantep

28046

H.U. La Paz., Madrid

29200

CHRU de Brest - La Cavale Blanche, Brest

30120

Hospital Universitario Virgen de la Arrixaca, El Palmar

30308

Emory University Hospital Midtown, Atlanta

30322

Emory University Hospital, Atlanta

Investigational Drug Service, Atlanta

34093

Istanbul University Oncology Institute, Istanbul

35040

Ege Universitesi Tip Fakultesi Cocuk Sagligi Ve Hastaliklari Anabilim Dali Pediatric Hematoloji, Bornova

Ege Universitesi Tip Fakultesi Hematoloji BD, Bornova

35392

Universitaetsklinikum Giessen, Giessen

39110

Mississippi Center for Advanced Medicine, Madison

40138

IRCCS - AOU di Bologna, Policlinico di Sant'Orsola, Bologna

40201

Chung Shan Medical University Hospital, Taichung

40705

Taichung Veterans General Hospital, Taichung

41944

Kyungpook National University Hospital, Daegu

44093

CHU Hôtel-Dieu, Nantes

46260

Indiana Hemophilia & Thrombosis Center, Inc., Indianapolis

47012

H.U. Rio Hortega, Valladolid

50134

SODc. Malattie Emorragiche e della Coagulazione Centro di Riferimento Regionale per le, Florence

53127

Universitatsklinikum Bonn. Anstalt des oeffentlichen Rechts, Bonn

66421

Universität und Universitätsklinikum des Saarlandes, Homburg/Saar

69677

Hôpital Cardiologique Louis Pradel, Bron

75015

Hopital Necker, Hematologie Adultes, Paris

80045

Hemophilia and Thrombosis Center at the University of Colorado Anschutz Medical Campus, Aurora

80131

UOC Medicina Interna - Malattie Emorragiche e Trombotiche, Napoli

89135

Alliance for Childhood Diseases, Las Vegas

94143

University of California, San Francisco - Outpatient Hematology Clinic, San Francisco

94304

Clinical and Translational Research Unit (CTRU), Palo Alto

Lucile Packard Childrens Hospital, Palo Alto

94305

Stanford Health Care, Stanford

98104

Bloodworks NW, Seattle

5262000

The Chaim Sheba Medical Center, The National Hemophilia Center, Tel Litwinsky

29047-105

Centro Estadual de Hemoterapia e Hematologia Marcos Daniel Santos - Hemoes, Vitória

66033-000

Centro de Hemoterapia e Hematologia do Para - Fundação HEMOPA, Belém

13083-878

Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP, Campinas

14051-140

Hospital Das Clínicas Da Faculdade de Medicina de Ribeirao Preto Da Universidade de Sao Paulo, Ribeirão Preto

20211-030

lnstituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO, Rio de Janeiro

05403-000

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo

L8N 3Z5

McMaster University Medical Centre - Hamilton Health Sciences, Hamilton

M5B 1W8

St. Michael's Hospital, Toronto

00161

"Università degli studi di Roma La Sapienza- Policlinico Umberto I", Roma

466-8560

Nagoya University Hospital - Transfusion Medicine, Nagoya

004-0041

Sapporo Tokushukai Hospital, Sapporo

634-8522

Nara Medical University Hospital, Kashihara

350-0495

Saitama Medical University Hospital, Iruma-gun

157-8535

National Center for Child Health and Development, Setagaya-ku

167-0035

Ogikubo Hospital, Suginami-ku

Unknown

King Faisal Specialist Hospital & Research Center, Riyadh

03722

Severance Hospital, Yonsei University Health System, Seoul

05278

Kyung Hee University Hospital At Gangdong, Seoul

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08035

Hospital Universitari Vall d´Hebrón, Barcelona

205 02

Skåne University Hospital, Malmo

01130

Acibadem Adana Hospital, Department of Pediatric Hematology, Adana

07070

Akdeniz University Medical Faculty Hospital, Antalya

NE1 4LP

Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

Non Malignant Haematology Research Unit, Newcastle upon Tyne

G31 2ER

Clinical Research Facility, Glasgow

G4 0SF

Department of Haematology, Glasgow

SE1 7EH

Guy's and St Thomas' NHS Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT03587116 - A Study to Evaluate Prospective Efficacy and Safety Data of Current FIX Prophylaxis Replacement Therapy in Adult Hemophilia B Subjects (FIX:C≤2%) or Current FVIII Prophylaxis Replacement Therapy in Adult Hemophilia A Subjects (FVIII:C≤1%) | Biotech Hunter | Biotech Hunter