NCT02476942已完成不适用
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 35
- 主要终点
- Number of Bleeds
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Bypassing Agents (Drug)
Cohort C: Adults and Adolescents without FVIII Inhibitors
Adults and adolescents with severe hemophilia A without the presence of FVIII inhibitors will be observed.
干预措施: FVIII Replacement (Drug)
结局指标
主要结局
Number of Bleeds
时间窗: Approximately 6 months (from Baseline until study completion)
次要结局
- 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))
研究者
研究点 (35)
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