NCT00571727已完成2 期
A Study of Long-Term Human Recombinant Insulin-Like Growth Factor-1 (rhIGF-1) in Children With Short Stature Due to Growth Hormone Insensitivity Syndrome (GHIS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Annualized Height Velocity Up to 12 Years
研究概览
简要总结
The objective of this study was to evaluate the long-term safety and effectiveness of mecasermin (the study drug) in children with growth failure due to severe Primary insulin-like growth factor-1 deficiency (Primary IGFD).
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
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Height <-2SD for age and gender
- •IGF-1 <-2SD for age and gender
- •Evidence of GH resistance
排除标准
- •closed epiphyses
- •prior active malignancy
- •major organ disfunction
- •treatment with medications that would diminish growth
- •clinically significant cardiac abnormalities
研究组 & 干预措施
mecasermin, injections BID of rhIGF-1
Experimental
干预措施: mecasermin (Drug)
结局指标
主要结局
Annualized Height Velocity Up to 12 Years
时间窗: Baseline (Pre-dose) and up to 12 years
Height velocity is the difference between 2 height measurements, divided by years elapsed between measurements.
Number of Naive Participants With Height Velocity <5 cm/y at the End of 1 Year of Study Treatment
时间窗: Baseline (Pre-dose) and 1 year
Height measurements were performed using wall-mounted stadiometers for analysis of growth data.
次要结局
- Approximate Increase in Height Over Expected for Naïve Participants With Near-Adult Height(Baseline (Pre-dose) and up to 19 years)
- Height Velocity Standard Deviation Score Up to 12 Years(Baseline (Pre-dose) and up to 12 years)
- Height Standard Deviation Score Up to 12 Years(Baseline (Pre-dose) and up to 12 years)
研究者
研究点 (1)
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