An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 72
- 主要终点
- Overall Summary of Adverse Events
研究概览
简要总结
This is an open label extension study of romiplostim for treatment of thrombocytopenia (platelet count ≤ 50 x 10^9/L) in MDS subjects. The study is designed to assess the long-term safety of treatment with romiplostim, as measured by incidence of overall adverse events, the incidence of bleeding events, the utilization of platelet transfusions, and the duration of platelet response. The study will further describe the time to disease progression to acute myeloid leukemia (AML) and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Open Label Romiplostim (formerly AMG 531)
干预措施: Romiplostim (formerly AMG 531) (Drug)
结局指标
主要结局
Overall Summary of Adverse Events
时间窗: During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks .
Incidence of Antibody (AB) Formation
时间窗: During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks.
次要结局
- Duration of Platelet Response(During treatment period. The average duration of romiplostim exposure is 56 weeks.)
- Weekly Bleeding Events Per 100 Subject Years(During the treatment period. The average duration of romiplostim exposure is 56 weeks.)
- Platelet Transfusion Events Per 100 Subject Years(During the treatment period. The average duration of romiplostim exposure is 56 weeks.)
- Weeks With Platelet Response Per Year(During the treatment period. The average duration of romiplostim exposure is 56 weeks.)
- Time to First Platelet Response(During treatment period. The average duration of romiplostim exposure is 56 weeks.)