A Prospective Study to Collect High-Quality Documentation of Bleeds, Health-Related Quality of Life (HRQoL), and Safety Outcomes in Patients With Hemophilia A Treated With Standard-of-Care Treatment

CompletedOBSERVATIONAL
Enrollment

221

Participants

Timeline

Start Date

May 26, 2015

Primary Completion Date

March 31, 2017

Study Completion Date

March 31, 2017

Conditions
Hemophilia A
Interventions
DRUG

Bypassing Agents

Episodic or prophylactic treatment with the use of bypassing agents must be documented for at least the last 6 months prior to the study. During the study, treatment for bleeds will be documented. The choice of coagulation product is at the discretion of the investigator according to local practice standards in this non-interventional study and there are no specific protocol-defined interventions.

DRUG

FVIII Replacement

Episodic or prophylactic treatment with the use of FVIII replacement must be documented for at least the last 6 months prior to the study. During the study, treatment for bleeds will be documented. The choice of coagulation product is at the discretion of the investigator according to local practice standards in this non-interventional study and there are no specific protocol-defined interventions.

Trial Locations (35)

100

National Taiwan Uni Hospital, Taipei

1000

ICIC, San José

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

15213

University of Pittsburgh, Pittsburgh

20007

Georgetown Uni Medical Center; Lombardi Cancer Center, Washington D.C.

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

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 (AöR); Inst. für Experimentelle Hämatologie u. Transfusionsmedizin (IHT), Bonn

80045

University of Colorado Denver, Children's Hospital, Aurora

90403

Santa Monica Oncology Center, Santa Monica

97201

Oregon Health & Science Uni ; Dept of Pediatrics, Portland

98104

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

100730

Peking Union Medical College Hospital, Beijing

300020

Tianjin Institute of Hematology & Blood Diseases Hospital, Tianjin

510515

Nanfang Hospital, Southern Medical University, Guangzhou

70112-2699

Tulane Uni Health Sciences Center, New Orleans

466-8560

Nagoya University Hospital, Aichi

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

634-8521

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

61-828

ALVAMED Lekarskie Gabinety Specjalistyczne, Poznan

02-776

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

03722

Severance Hospital, Seoul

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02476942 - A Prospective Study to Collect High-Quality Documentation of Bleeds, Health-Related Quality of Life (HRQoL), and Safety Outcomes in Patients With Hemophilia A Treated With Standard-of-Care Treatment | Biotech Hunter | Biotech Hunter