Revolade Tablets Specified Drug-use Survey (Pediatric Aplastic Anemia Naive to Treatment With Anti-thymocyte Immunoglobulin, CETB115G1401)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 17
- 主要终点
- Occurrence of serious adverse events
研究概览
简要总结
This is a multicenter, single-arm, non-interventional study (NIS) to confirm the safety and efficacy of eltrombopag in Anti-Thymocyte Globulin (ATG) treatment naive pediatric patients with aplastic anemia (AA).
详细描述
The objective of this survey is to confirm the safety and efficacy of eltrombopag in ATG treatment naive pediatric patients with AA. Eltrombopag should be administered according to the dosage and administration specified in the latest version of the package insert. The observation period is 1 year (364 days) from the start of treatment with this product, regardless of whether treatment with eltrombopag is continued or not. However, if hematopoietic stem cell transplantation is performed within 1 year after the start of treatment with eltrombopag, the observation period shall be until the date of hematopoietic stem cell transplantation.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose legally acceptable representative has given written consent for cooperation in this survey prior to enrollment in this survey
- •Patients aged ≥ 6 years and < 18 years at the start of treatment with eltrombopag
- •Pediatric patients with AA who receive eltrombopag for the first time in combination with ATG after the approval of additional dosage and administration for "ATG-naïve pediatric patients with AA"
排除标准
- •Patients who have received ATG without concomitant use of eltrombopag
- •Patients with congenital AA
- •Patients with suspected or confirmed diagnosis of myelodysplastic syndrome (MDS) at the start of treatment with eltrombopag
- •Patients who have received any drug products containing the same ingredient as eltrombopag (including investigational products)
研究组 & 干预措施
eltrombopag
ATG treatment naïve pediatric patients with AA in routine clinical practice
干预措施: eltrombopag (Other)
结局指标
主要结局
Occurrence of serious adverse events
时间窗: Up to 1 year
Occurrence of serious adverse events to be provided
次要结局
- Occurrence of adverse events and adverse drug reactions leading to treatment discontinuation(Up to 1 Year)
- Occurrence of adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies)(Up to 1 year)
- Change over time from baseline in hemoglobin(Baseline, 1 year)
- Change over time from baseline in transfusion volume(Baseline, 1 year)
- Occurrence of clonal evolution(Up to 1 year)
- Hematologic response status(Up to 1 year)
- Change over time from baseline in platelet count(Baseline, 1 year)
- Change over time from baseline in neutrophil count(Baseline, 1 year)
- Change over time from baseline in reticulocyte count(Baseline, 1 year)
- Change over time from baseline in transfusion dependence(Baseline, 1 year)