NCT03932201进行中（未招募）不适用
Observational Study Evaluating Effectiveness and Safety of Real-World Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A
Bayer38 个研究点 分布在 20 个国家目标入组 371 人开始时间: 2019年10月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 371
- 试验地点
- 38
- 主要终点
- Median annualized number of reported total bleeds in patients with hemophilia A
研究概览
简要总结
The aim of the HEM-POWR study is to understand better how Damoctocog alfa pegol (Jivi) is used to treat people with Hemophilia A in day-to-day life, how well the treatment is tolerated and how satisfied patients and physicians are with the treatment.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hemophilia A.
- •Patients previously treated for Hemophilia A.
- •Patients without previous history of inhibitors or patients with previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry.
- •No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor.
- •Initiation of or currently on damoctocog alfa pegol with any kind of treatment modality (on-demand, prophylaxis, or intermittent prophylaxis).
- •Signed informed consent/assent.
排除标准
- •Concurrent participation in an investigational program with interventions outside of routine clinical practice.
- •Diagnosis of any other bleeding/coagulation disorder other than hemophilia A.
- •Contra-indications according to the local marketing authorization.
- •Patient on immune tolerance induction (ITI) treatment at the time of enrollment.
研究组 & 干预措施
Previously treated patient (PTPs) with hemophilia A
Previously treated patients with hemophilia A receiving damoctocog alfa pegol with any kind of treatment modality (on-demand, prophylaxis, or intermittent prophylaxis)。
干预措施: Damoctocog alfa pegol (Jivi, Bay94-9027) (Drug)
结局指标
主要结局
Median annualized number of reported total bleeds in patients with hemophilia A
时间窗: Up to 36 months
Mean annualized number of reported total bleeds in patients with hemophilia A
时间窗: Up to 36 months
次要结局
- Joint status evaluation by ultrasound (HEAD-US score), if available or part of standard clinical practice.(Up to 36 months)
- Change of number of affected joints by patient(From baseline to 12 months, 24 months and 36 months)
- Annualized number of spontaneous, joint, and trauma bleeds(Up to 36 months)
- Half-life [t½] for previous FVIII products versus damoctocog alfa pegol.(Up to 36 months)
- Duration of AEs.(Up to 36 months)
- Outcome of AEs.(Up to 36 months)
- Number of infusions and FVIII consumption to achieve hemostasis during surgery(Up to 36 months)
- Changes of Hemo-QoL (A and SF) score(From baseline to 12 months, 24 months and 36 months)
- Treatment of AEs.(Up to 36 months)
- Number of reported bleeds during the study compared with number of reported bleeds for previous FVIII products in the 12 months prior to enrollment into the study.(Up to 36 months)
- Proportion of patients with 0 bleeds, and the difference in proportion comparing to previous prophylaxis treatment.(Up to 36 months)
- FVIII peak levels for previous FVIII products versus damoctocog alfa pegol.(Up to 36 months)
- In-vivo recovery for previous FVIII products versus damoctocog alfa pegol.(Up to 36 months)
- Changes of Hemo-SAT A score(From baseline to 12 months, 24 months and 36 months)
- Occurrence of AEs.(Up to 36 months)
- Severity of AEs.(Up to 36 months)
- Change in joint scores (HJHS)(From baseline to 12 months, 24 months and 36 months)
- AUC for previous FVIII products versus damoctocog alfa pegol.(Up to 36 months)
- FVIII trough for previous FVIII products versus damoctocog alfa pegol.(Up to 36 months)
- Number of infusions to control for a bleed(Up to 36 months)
- Changes of WPAI score(From baseline to 12 months, 24 months and 36 months)
研究者
研究点 (38)
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