An Observational Cohort Study of the Use of Avatrombopag in Patients With Thrombocytopenia Associated With Chronic Liver Disease Undergoing a Procedure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Sobi, Inc.
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Change in platelet count
研究概览
简要总结
Phase 4 observational cohort study to characterize the treatment patterns and effects of avatrombopag use in patients with thrombocytopenia associated with chronic liver disease who are either undergoing, or have already undergone, a procedure.
详细描述
Data (e.g. type of procedure, platelet count, etc.) will be collected retrospectively or prospectively from patient visits occurring within approximately 7 calendar days prior to the first dose of avatrombopag, on Procedure Day, on Discharge Day, and from any clinic visit performed up to 30 days post-procedure. All treatment decisions and clinical assessments will be at the discretion of the treating physician per routine medical care and are not mandated by study design or protocol.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has thrombocytopenia associated with chronic liver disease and is planned for or underwent treatment with avatrombopag prior to a procedure
- •Patient provides written informed consent
- •Minimum Data for Retrospective Enrollment
- •Platelet count from approximately 7 days prior to starting avatrombopag
- •Platelet count on Procedure Day
排除标准
- 未提供
结局指标
主要结局
Change in platelet count
时间窗: Up to 8 days after the last dose of avatrombopag.
次要结局
- Proportion of patients who received a platelet transfusion(From the first dose of avatrombopag to up to 15 days after the last dose of avatrombopag)
- Occurrence of adverse events(From the first dose of avatrombopag to up to 30 days after the last dose of avatrombopag)