Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of IgPro20 in Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Subjects Completing Study IgPro20_3003
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 82
- 试验地点
- 33
- 主要终点
- Number of Adverse Events (AEs) Per Infusion
研究概览
简要总结
This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with regard to safety and efficacy.
Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight [bw]) weekly for up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment. Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.
The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects having completed the pivotal study IgPro20_3003 (SC Week 25) or successfully rescued from a CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076).
- •Written informed consent for study participation obtained before undergoing any study-specific procedures.
排除标准
- •Subject is unable to directly transition from study IgPro20_
- •New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse) during participation in study IgPro20_3003 that in the judgment of the investigator could increase risk to the subject, interfere with the evaluation of investigational medicinal product, and/or conduct of the study.
研究组 & 干预措施
IgPro20
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg bw (low-dose IgPro20) for up to 48 weeks. Subjects who experience CIDP relapse on 0.2 g/kg IgPro20 will have an increase to 0.4 g/kg IgPro20 immediately and will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment.
干预措施: IgPro20 (Biological)
结局指标
主要结局
Number of Adverse Events (AEs) Per Infusion
时间窗: Up to 49 weeks
次要结局
- Number of Serious AEs Per Infusion(Up to 49 weeks)
- Number of AEs by Severity Per Infusion(Up to 49 weeks)
- Percentage of Subjects With AEs by Severity(Up to 49 weeks)
- Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score(Baseline and up to 49 weeks)
- Percentage of Subjects With Serious AEs(Up to 49 weeks)
- Percentage of Subjects With Causally Related AEs(Up to 49 weeks)
- Time to First CIDP Relapse(Up to 49 weeks)
- Change From Baseline in Medical Research Council (MRC) Score(Baseline and up to 49 weeks)
- Change From Baseline in Rasch-built Overall Disability Scale (R-ODS)(Baseline and up to 49 weeks)
- Percentage of Subjects With Adverse Events (AEs)(Up to 49 weeks)
- Change From Baseline in Mean Grip Strength(Baseline and up to 49 weeks)
- Number of Causally Related AEs Per Infusion(Up to 49 weeks)