An Open-label, Unit Dose-finding Study Evaluating the Safety and Efficacy of Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 16
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Greater than or equal to 3 months history of ITP, regardless of splenectomy status, and completion of at least 1 prior treatment for ITP
- •2 of 3 pretreatment platelet counts that were less than 30 x 10^9/L (if not currently on ITP therapy) or less than 50 x 10^9/L (if currently receiving corticosteroids for ITP therapy)
- •Ability to give informed consent
排除标准
- •Known history of arterial thrombosis, active malignancy, or bone marrow stem cell disorder
研究组 & 干预措施
Romiplostim
Participants will receive a maximum of 2 administrations of romiplostim by subcutaneous injection, the first on day 1 of the study and the second on day 15 or 22 depending on the participant's platelet count. Romiplostim doses to be tested were 30, 100, 300, and 500 μg.
干预措施: Romiplostim (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From first dose through 8 weeks after last dose of study drug (11 weeks)
Number of Participants With Positive Anti-Romiplostim Antibodies
时间窗: Days 29 and 78
The presence or development of antibodies to romiplostim and endogenous thrombopoietin was assessed using a neutralizing bioassay. Antibody analyses were conducted on study days 29 and at the end-of-study visit (day 78). The number of participants with positive antibody binding at any time during the study is reported.
次要结局
- Time to Peak Platelet Count(From first dose of study drug to day 15 or 22, and from the second dose of study drug (day 15 or 22) to day 78)
- Number of Participants Who Achieved a Targeted Therapeutic Platelet Response(Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants))
- Change From Baseline to Peak Platelet Level(Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants))
- Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L From Baseline(Baseline and after first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22) and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 in all participants))
- Number of Participants With Peak Platelet Counts of ≥ 100 x 10⁹ Cells/L(After first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22), and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants))
- Number of Participants With Peak Platelet Counts of ≥ 450 x 10⁹ Cells/L(After first dose (days 3, 5, 8, 10, 12, 15, and days 17 and 19 for participants dosed on day 22), and after second dose (days 17, 19, and 22 for participants dosed on day 15, and days 24, 26, 29, 32, 36, 43, 50, 64, and 78 for all participants))
- Duration Within the Targeted Therapeutic Range(From first dose of study drug to day 15 or 22, and from the second dose of study drug (day 15 or 22) to day 78)