NCT00116688已完成3 期
An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 313
- 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 determine the safety of romiplostim as a long-term treatment in thrombocytopenic subjects with ITP, to evaluate the long-term platelet response to romiplostim, and to evaluate changes in patient reported outcomes due to the use of romiplostim. Participants must have previously completed a romiplostim ITP study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have previously completed a romiplostim ITP study
- •Platelet count ≤ 50 x 10 ^9/L
- •Written informed consent
排除标准
- •Bone marrow stem cell disorder or new active malignancies diagnosed since enrollment in the previous romiplostim ITP study
- •Received any alkylating agents within 4 weeks before screening visit or anticipated use during the time of the proposed study
- •Currently enrolled in or has not yet completed at least 4 weeks since ending device or drug trial(s) (other than the previous romiplostim ITP study), or subject is receiving other investigational agent(s) other than romiplostim
- •Not using adequate contraceptive precautions
- •Not available for follow-up assessments
- •Has any kind of disorder that compromises the ability of the participant to give informed consent and does not have a legally-acceptable representative and/or is unable to comply with study procedures.
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Duration of treatment plus 8 weeks (up to 285 weeks)
Participants with one or more occurrences of one or more adverse events up to 8 weeks after the end of treatment. Participants with more than one event were only counted once.
次要结局
- Change From Baseline in Euroqol-5D (EQ-5D) Index Score(Baseline to Week 48)
- Change From Baseline in Euroqol-5D (EQ-5D) Visual Analogue Scale (VAS)(Baseline to Week 48)
- Patient Global Assessment(Week 1 and Week 48)
- Number of Participants With a Platelet Response(Duration of treatment (up to 277 weeks))
- Number of Participants With a Reduction or Discontinuation of Concurrent ITP Therapies(Duration of treatment (up to 277 weeks))
- Change From Baseline in ITP Patient Assessment Questionnaire(Baseline to Week 48)
- Change From Baseline in Short Form 36 (SF-36)(Baseline to Week 48)
研究者
相似试验
已完成
2 期
Determination of Safe Dose of Romiplostim (AMG 531) in Patients With Myelodysplastic Syndromes (MDS)MDSMyelodysplastic SyndromesRefractory CytopeniasThrombocytopeniaNCT00303472Amgen72
已完成
3 期
An Open Label Extension of a Study of Topiramate in Chronic Migraine.MigraineNCT00210873Johnson & Johnson Pharmaceutical Research & Development, L.L.C.200
已完成
3 期
An Open Label Extension of a Study Comparing Topiramate and Amitriptyline in Migraine Prevention.MigraineNCT00210860Johnson & Johnson Pharmaceutical Research & Development, L.L.C.142
已完成
不适用
Evaluating the Safety of Long Term Dosing of Romiplostim (Formerly AMG 531) in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)HematologyMDSMyelodysplastic SyndromesThrombocytopeniaNCT00472290Amgen72
已完成
3 期
A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid ArthritisRheumatoid ArthritisNCT01214733Hoffmann-La Roche30