NCT02035384已完成不适用
A Multi-centre Non-interventional Study of Safety and Efficacy of Turoctocog Alfa (rFVIII) During Long-Term Treatment of Severe and Moderately Severe Haemophilia A (FVIII =<2%)
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
- 69
- 试验地点
- 1
- 主要终点
- Incidence rate of FVIII inhibitors (at least 0.6 Bethesda Units (BU) for central laboratory analyses, or above the specific local laboratory reference range) represented as the percentage of patients developing inhibitors
研究概览
简要总结
This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any study-related activities. Study-related activities are any procedure related to recording of data according to the protocol
- •Previously FVIII treated (150 exposure days at the time of first dosing with turoctocog alfa) male patients with the diagnosis of severe and moderately severe haemophilia A (FVIII below or equal to 2%)
- •The decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/parent and the patient's treating physician before and independently from the decision to include the patient in this study
- •A negative FVIII inhibitor test obtained not more than four weeks prior to first dosing with turoctocog alfa
排除标准
- •Contraindications for use according to the approved product information text (US Package insert (PI), European Summary of Product Characteristics (SmPC), or corresponding local prescribing information)
- •Treatment with any investigational drug within 30 days prior to enrolment into the study
- •Previous participation in any clinical trial with turoctocog alfa
- •Treatment with other FVIII products after initiation of treatment with turoctocog alfa
研究组 & 干预措施
All patients
干预措施: turoctocog alfa (Drug)
结局指标
主要结局
Incidence rate of FVIII inhibitors (at least 0.6 Bethesda Units (BU) for central laboratory analyses, or above the specific local laboratory reference range) represented as the percentage of patients developing inhibitors
时间窗: Within approximately 7 years
次要结局
- Haemostatic effect of turoctocog alfa in the treatment of bleeds as assessed by the patient or the physician according to a predefined four point scale: Excellent, Good, Moderate, or None(Within approximately 7 years)
- Number of adverse reactions reported(During approximately 7 years)
- Number of serious adverse reactions reported(During approximately 7 years)
- Haemostatic effect of turoctocog alfa during surgical procedures as assessed by an evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None(Within approximately 7 years)
- Annualised bleeding rate for patients using turoctocog alfa for preventive treatment(Within approximately 7 years)
- Annualised bleeding rate for patients using turoctocog alfa for on-demand treatment(Within approximately 7 years)
研究者
研究点 (1)
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