NCT07415083已完成不适用
Retrospective Chart Review of Safety and Effectiveness of Eltrombopag in Combination With Immunosuppressive Therapy (IST) in Korean Pediatric Patients With Treatment Naïve Severe Aplastic Anemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The aim of this study was to investigate the safety, tolerability, and effectiveness of eltrombopag in combination with immunosuppressive therapy (IST) in real world practice in pediatric patients with severe aplastic anemia (sAA) in Korea. The study used data over a 6-month period extracted from patients' medical charts (electronic medical records) starting from the initiation of eltrombopag treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female pediatric patients aged ≥2 years and <18 years at the time of initiating eltrombopag and IST treatment.
- •Subjects diagnosed with sAA and treated with eltrombopag in combination with IST as first-line therapy, based on the physician's decision in accordance with locally approved prescribing information at the time of data collection.
- •Subjects whose analytical index date (start date of eltrombopag administration) was at least 6 months prior to the data extraction date.
排除标准
- 未提供
研究组 & 干预措施
Eltrombopag and IST Treatment Cohort
Pediatric patients with sAA who received first-line eltrombopag in combination with IST.
结局指标
主要结局
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to 6 months
Incidence of all AEs/adverse drug reactions (ADRs), SAEs/serious adverse drug reactions (SADRs), and unexpected AEs/ADRs.
次要结局
- Overall Response Rate (ORR)(6 months)
研究者
研究点 (1)
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