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
- 25
- 主要终点
- Frequency and severity of adverse events associated with the use of the GNR-069
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
结局指标
主要结局
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.
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.
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)