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
Completed
Conditions studied: Hemophilia A
In brief
This non-interventional study will prospectively collect detailed, high-quality documentation of bleeds, HRQoL, and safety in patients with hemophilia A with or without FVIII inhibitors treated according to local routine clinical practice (receiving FVIII replacement or bypassing agents as either episodic or prophylactic treatment). Actual patients will be enrolled from routine clinical practice in this observational study.
Key facts
- Study ID
- NCT02476942
- Run by
- Hoffmann-La Roche
- People needed
- 221
- Starts
- 2015-05-26
- Expected to finish
- 2017-03-31
- Last updated by the study team
- 2017-05-30
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Cohort A: Patients greater than or equal to (>/=) 12 years of age at time of informed consent
- 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
You may not qualify if…
- Prior RO5534262 (not applicable if patient agrees that prior RO5534262 will preclude participation in a future investigational RO5534262 study)
- 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)
Where it is running
- 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
Full record on ClinicalTrials.gov
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