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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hemophilia A

Intervention / Treatment
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* Drug: Bypassing Agents
* Drug: FVIII Replacement


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A: Adults and Adolescents with FVIII Inhibitors<br>Adults and adolescents with hemophilia A of any severity with the presence of FVIII inhibitors will be observed. | Drug: Bypassing Agents<br>* 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.<br>|
| Cohort B: Children with FVIII Inhibitors<br>Children with hemophilia A of any severity with the presence of FVIII inhibitors will be observed. | |
| Cohort C: Adults and Adolescents without FVIII Inhibitors<br>Adults and adolescents with severe hemophilia A without the presence of FVIII inhibitors will be observed. | Drug: FVIII Replacement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Bleeds |  | Approximately 6 months (from Baseline until study completion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| European Quality of Life-5 Dimensions (EQ-5D-5L) Questionnaire Score Among Adult and Adolescent Patients |  | Approximately 6 months (every 4 weeks from Baseline until study completion and on days that bleeds are reported) | 
| Hemophilia A-Specific Quality of Life (Haem-A-QoL) Questionnaire Score Among Adult Patients |  | Approximately 6 months (every 4 weeks from Baseline until study completion) | 
| Hemophilia-Specific Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Score |  | Approximately 6 months (every 4 weeks from Baseline until study completion) |