Specified Drug-use Surveillance of Fabhalta Capsules (Paroxysmal Nocturnal Hemoglobinuria, CLNP023C11401)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 132
- 试验地点
- 160
- 主要终点
- Occurrence status of infections.
研究概览
简要总结
This is a multicenter, single-arm, non-interventional study (NIS) with a central registration system and an all-case surveillance system. The observation period is 48 weeks after the start of treatment with Fabhalta.
详细描述
The observation period will be 48 weeks after the start of treatment with Fabhalta.
For patients in whom treatment with Fabhalta is discontinued within 48 weeks after the start of the treatment, adverse events occurring by the last day of the treatment + 30 days and concomitant drugs will be monitored and recorded in CRFs.
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
- 0 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who received Fabhalta.
排除标准
- •Patients receiving Fabhalta for an unapproved indication under the Clinical Trials Act or GCP.
结局指标
主要结局
Occurrence status of infections.
时间窗: 48weeks
Type, incidence, seriousness, severity, clinical course, factors affecting onset (status of vaccination, name of vaccine administered, complications, baseline white blood cell count/neutrophil count, etc.), and causative organism (including serotype) of adverse events/adverse drug reactions of infections during the treatment period.
次要结局
- Occurrence status of serious hemolysis after discontinuation of Fabhalta.(48weeks)
- Occurrence status of adverse events and adverse drug reactions.(48weeks)
- Incidence of breakthrough hemolysis and change of hemolysis-related markers and status of red blood cell transfusion-free.(48weeks)