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
NCT ID: NCT02476942
Last Updated: 2017-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
221 participants
OBSERVATIONAL
2015-05-26
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Cohort A: Adults and Adolescents with FVIII Inhibitors
Adults and adolescents with hemophilia A of any severity with the presence of FVIII inhibitors will be observed.
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.
Cohort B: Children with FVIII Inhibitors
Children with hemophilia A of any severity with the presence of FVIII inhibitors will be observed.
No interventions assigned to this group
Cohort C: Adults and Adolescents without FVIII Inhibitors
Adults and adolescents with severe hemophilia A without the presence of FVIII inhibitors will be observed.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Cohort A: Diagnosis of congenital hemophilia A of any severity and documented history of high-titer inhibitor (that is, \>/= 5 Bethesda units \[BU\])
* Cohort B: Pediatric patients less than (\<) 12 years of age
* Cohort B: Diagnosis of congenital hemophilia A of any severity and documented history of high-titer inhibitor (that is, \>/=5 BU)
* Cohort C: Patients \>/=12 years of age
* Cohort C: Diagnosis of congenital hemophilia A and FVIII activity \<1 percent (%)
* Cohort C: No prior history of a positive inhibitor against FVIII
Exclusion Criteria
* Bleeding disorder other than congenital hemophilia A
* Ongoing (or planned during the study) immune tolerance induction therapy with FVIII or FVIII prophylaxis if currently/previously exposed to an inhibitor
* Previous or concomitant thromboembolic disease
* Known human immunodeficiency virus (HIV) infection with cluster of differentiation (CD) 4 count \<200 cells per microliter (cells/mcL)
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Santa Monica Oncology Center
Santa Monica, California, United States
University of Colorado Denver, Children's Hospital
Aurora, Colorado, United States
Georgetown Uni Medical Center; Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Tulane Uni Health Sciences Center
New Orleans, Louisiana, United States
Children's Hospital of Michigan; Pediatrics
Detroit, Michigan, United States
Cornell Univ Medical College; Hematology-Oncolog
New York, New York, United States
Oregon Health & Science Uni ; Dept of Pediatrics
Portland, Oregon, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Bloodworks Northwest (formerly Puget Sound Blood Center); Hemophilia
Seattle, Washington, United States
Royal Prince Alfred Hospital; Haematology
Camperdown, New South Wales, Australia
The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit
Melbourne, Victoria, Australia
Peking Union Medical College Hospital
Beijing, , China
Nanfang Hospital, Southern Medical University
Guangzhou, , China
Tianjin Institute of Hematology & Blood Diseases Hospital
Tianjin, , China
ICIC
San José, , Costa Rica
Universitätsklinikum Bonn (AöR); Inst. für Experimentelle Hämatologie u. Transfusionsmedizin (IHT)
Bonn, , Germany
IRCCS Ca' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi "Angelo Bianchi e Bonomi"
Milan, Lombardy, Italy
AOU Careggi; SOD Malattie Emorragiche
Florence, Tuscany, Italy
Nagoya University Hospital
Aichi, , Japan
Hyogo College of Medicine Hospital
Hyōgo, , Japan
St. Marianna University School of Medicine Hospital
Kanagawa, , Japan
Hospital of the University of Occupational and Environmental Health,Japan
Kitakyushu-shi, , Japan
Nara Medical University Hospital
Nara, , Japan
Tokyo Medical University Hospital
Tokyo, , Japan
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
Gdansk, , Poland
SPSK Nr1 Klinika Hematoo&Transpl.Szpiku
Lublin, , Poland
ALVAMED Lekarskie Gabinety Specjalistyczne
Poznan, , Poland
Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych
Warsaw, , Poland
Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center
Johannesburg, , South Africa
Severance Hospital
Seoul, , South Korea
Hospital Universitario la Paz; Servicio de Hematologia
Madrid, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Hematologia
Seville, , Spain
Hospital Universitario la Fe; Servicio de Hematologia
Valencia, , Spain
National Taiwan Uni Hospital
Taipei, , Taiwan
Countries
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References
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Oldenburg J, Shima M, Kruse-Jarres R, Santagostino E, Mahlangu J, Lehle M, Selak Bienz N, Chebon S, Asikanius E, Trask P, Mancuso ME, Jimenez-Yuste V, von Mackensen S, Levy GG. Outcomes in children with hemophilia A with inhibitors: Results from a noninterventional study. Pediatr Blood Cancer. 2020 Oct;67(10):e28474. doi: 10.1002/pbc.28474. Epub 2020 Aug 9.
Other Identifiers
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BH29768
Identifier Type: -
Identifier Source: org_study_id
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