HYMPAVZI S.C. INJECTION 150 MG PEN SPECIAL INVESTIGATION
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of the participants with adverse drug reactions
研究概览
简要总结
A study to evaluate the safety of Hympavzi under the actual use in patients with congenital hemophilia who do not have inhibitors.
详细描述
The objective of this study is to assess the safety of this drug under actual usage conditions in patients with congenital hemophilia who do not have inhibitors.
The observation period will be up to three years. However, for cases in which administration of the drug is discontinued, information will be collected up to the point of discontinuation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •to be eligible for inclusion in the study:
- •Patients who have received at least one dose of this drug after the launch of this drug
排除标准
- 未提供
研究组 & 干预措施
Marstacimab
hemophilia patients without inhibitor
干预措施: Marstacimab (Drug)
结局指标
主要结局
Number of the participants with adverse drug reactions
时间窗: The evaluation period is from the first dose of Himpavzi up to 156 weeks (3 years).
An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to Himpavzi in a participant who received Himpavzi. A serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Himpavzi was assessed by the physician.
次要结局
未报告次要终点