NCT04798690招募中不适用
Open, Multi-center, Non-interventional, Prospective/ Retrospective Observational Study on Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Long term safety assessed through the adverse events
研究概览
简要总结
This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with short stature by growth hormone deficiency(GHD) or idiopathic short stature (ISS) or turner's syndrome(TS) or small for gestational age(SGA)
- •Children who has official height record at least 6 months prior
排除标准
- •Children with Epiphyseal closure
研究组 & 干预措施
Growth hormone
Growtropin®-II
结局指标
主要结局
Long term safety assessed through the adverse events
时间窗: Up to 2 years after epiphyseal closure
Number of occurrence of treatment-related adverse events
次要结局
- Changes in Height SDS(Up to 2 years after epiphyseal closure)
- The difference between target height and final height(Up to 2 years after epiphyseal closure)
- Changes in skeletal maturity(Up to 2 years after epiphyseal closure)
- Changes in IGF-1(Up to 2 years after epiphyseal closure)
- Changes in BMI SDS(Up to 2 years after epiphyseal closure)
- Change of annualized height velocity(Up to 2 years after epiphyseal closure)
- Changes in IGFBP-3(Up to 2 years after epiphyseal closure)
研究者
研究点 (1)
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