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
| Status: | Completed |
|---|---|
| Conditions: | Anemia, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/29/2017 |
| Start Date: | May 26, 2015 |
| End Date: | April 5, 2017 |
A Multicenter, Non-Interventional Study Evaluating Bleeding Incidence, Health-Related Quality of Life, and Safety in Patients With Hemophilia A Under Standard-of-Care Treatment
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
We found this trial at
11
sites
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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921 Terry Avenue
Seattle, Washington 98104
Seattle, Washington 98104
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3970 Reservoir Road Northwest
Washington, D.C., District of Columbia 20007
Washington, D.C., District of Columbia 20007
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