NCT03684018招募中4 期
Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- CSL Behring
- 入组人数
- 30
- 试验地点
- 18
- 主要终点
- Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level
研究概览
简要总结
A randomized, open-label, prospective, multicenter study designed to investigate 2 dose levels in pediatric subjects 2 to ≤ 17 years of age with confirmed or possible CIDP, either previously exposed to IVIG treatment or unexposed to IVIG treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP.
排除标准
- •- Absence of CIDP symptoms
- •-History or family history of inherited neuropathy
- •-Diagnosed developmental delay or regression
- •-History of thrombotic episode
- •-Known or suspected hypersensitivity to Privigen
- •-Known allergic or other severe reactions to blood products
- •-Female subject of childbearing potential either not using or not willing to use a medically reliable method of contraception or not sexually abstinent during the study
- •-Pregnant or breastfeeding mother"
研究组 & 干预措施
IgPro10 (dose level 2)
Experimental
干预措施: IgPro10 (Biological)
IgPro10 (dose level 1)
Experimental
干预措施: IgPro10 (Biological)
结局指标
主要结局
Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level
时间窗: Approximately 24 weeks
CIDP relapse, defined as a clinical decline relative to the previous assessment as indicated by an increase in modified Rankin Scale (mRS) of ≥ 1 point, in the Randomized Phase
次要结局
- Rate of mild, moderate, and severe TEAEs per infusion by dose level(Approximately 56 weeks)
- Rate of serious TEAEs per infusion(Approximately 56 weeks)
- Percentage of subjects with related TEAEs(Approximately 56 weeks)
- Time to CIDP relapse in Randomized Phase by dose level(Approximately 24 weeks)
- Time to CIDP Relapse in the Dose Exploration Phase by dose level(Approximately 24 weeks)
- Percentage of subjects with treatment emergent adverse events (TEAEs) by dose level(Approximately 56 weeks)
- Percentage of subjects with serious TEAEs(Approximately 56 weeks)
- Percentage (%) of subjects with CIDP recovery in the Randomization Phase by dose level(Approximately 24 weeks)
- Rate of related TEAEs per infusion(Approximately 56 weeks)
- Percentage of subjects with CIDP relapse in the Dose Exploration Phase by dose level assigned in the Randomized Phase(Approximately 24 weeks)
- Percentage (%) of subjects with CIDP improvement in the Randomization Phase by dose level(Approximately 24 weeks)
- Rate of TEAEs per infusion(Approximately 56 weeks)
- Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase(Baseline and Approximately 24 weeks)
- Percentage (%) of subjects with CIDP improvement in the Dose Exploration Phase (DEP) by dose level(Approximately 24 weeks)
- Percentage (%) of subjects with CIDP recovery in the Dose Exploration Phase by dose level(Approximately 24 weeks)
研究者
研究点 (18)
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