Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 16
- 主要终点
- Incidence of therapy-related SAEs and level of severity
研究概览
简要总结
The overall objective is to enroll patients with acquired hemophilia A (AHA) who are prescribed and treated with Obizur, to assess safety, and to describe factors related to safety, utilization and effectiveness in a real-world setting.
详细描述
This study is a multi-center, uncontrolled, open-label, non-interventional post-marketing safety surveillance study to describe the use of Obizur in patients with acquired hemophilia A (AHA), and secondarily, where data are available, to describe the hemostatic effectiveness and immunogenicity of Obizur.
Patients should be enrolled at the earliest possible time point after initiating Obizur.
In an attempt to collect safety and utilization data on patients treated with Obizur since Food and Drug Administration (FDA) approval in October 2014, Baxalta will make an effort to identify all persons treated with Obizur and to collect data for as many patients as possible.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is ≥18 years of age at the time of informed consent.
- •Participant has AHA, and is being treated/was treated with Obizur.
- •Participant or the participant's legally authorized representative is willing and able to provide informed consent, unless informed consent is not required
排除标准
- •Participant has a known anaphylactic reaction to the active substance, to any of the excipients, or to hamster protein.
- •Participant has a concomitant bleeding disorder(s) other than acquired hemophilia A (AHA).
- •Participant has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of the study.
结局指标
主要结局
Incidence of therapy-related SAEs and level of severity
时间窗: Throughout the study period of approximately 4 years
次要结局
- Occurrence of any thrombogenic event(Throughout the study period of approximately 4 years)
- Titer of newly recognized anti-porcine Factor VIII (anti-pFVIII) neutralizing antibodies (inhibitors) or increase in titer of anti-pFVIII inhibitors from baseline and changes over time.(Throughout the study period of approximately 4 years)
- Occurrence of hypersensitivity reactions(Throughout the study period of approximately 4 years)
- Time to bleeding resolution, participant study termination, or switch to another treatment(Throughout the study period, up to approximately 4 years)
- Number of Obizur units/kg required for control of bleeding(Throughout the study period, up to approximately 4 years)
- Impact of the inhibitor on hemostatic efficacy and any associated clinical manifestations.(Throughout the study period of approximately 4 years)
- Hemostatic effectiveness assessment for resolution of bleeding(Throughout the study period, up to approximately 4 years)
- Number of Obizur infusions required for control of bleeding(Throughout the study period, up to approximately 4 years)