Extension Study of Long-term Safety and Immunogenicity of GNR-069 Patients With Idiopathic Thrombocytopenic Purpura Who Completed Phase 3 RMP-ITP-III Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AO GENERIUM
- 入组人数
- 160
- 试验地点
- 13
- 主要终点
- Number of undesirable events of particular interest in the study (Bleeding;Thrombotic/thromboembolic events)
研究概览
简要总结
It is a phase III extension study to assess safety and immunogenicity of long-term therapy with GNR-069 in patients with idiopathic thrombocytopenic purpura
详细描述
It is an extension study in patients with ITP who completed participation in RMP-ITP-III clinical trial.
The study will be conducted in three stages:
- Transition visit - 1 day (transition of clinical trial participants from the RMP-ITP-III study to the RMP-ITP-III-X study);
- Treatment period - minimum 26 weeks;
- Follow-up period - 1 week. Patients will then be provided with the study therapy till the product market access with only safety data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of participation in the study RMP-ITP-III while maintaining the clinical effectiveness of romiplostim therapy
排除标准
- •Hypersensitivity to the components of the study drug or E. Coli proteins;
- •Pregnancy or breastfeeding;
- •Any diseases and conditions that, in the opinion of the Investigator, may hinder the patient's participation in the study
研究组 & 干预措施
GNR-069
Weekly subcutaneous injections of GNR-069 in the individually titrated dose.
干预措施: GNR-069 (Biological)
结局指标
主要结局
Number of undesirable events of particular interest in the study (Bleeding;Thrombotic/thromboembolic events)
时间窗: up to 29 weeks
The event of particular interest in this study are bleeding and thrombotic/thromboembolic events of any location.
Frequency and severity of adverse events associated with the use of the GNR-069
时间窗: up to 29 weeks
Adverse events will be assessed based on complaints, physical examination and laboratory data.
Number of clinically significant bleeding on Visits 1-5
时间窗: up to 29 weeks
The clinically significant bleeding will be considered events ≥ grade 2 according to CTCAE 5.0.
Number and proportion of the patient with antidrug antibodies.
时间窗: up to 29 weeks
The antidrug antibodies willl be characterized by their type, titer and neutralizing activity.
次要结局
- Frequency of the loss of the treatment response(up to 27 weeks)
- Platelet count dynamics at Visits 1-5(up to 5 weeks)
- Сhange in ITP-BAT bleeding scores from baseline to week 27(up to 27 weeks)