NCT01543867已完成不适用
Non-interventional Study of the Safety and Efficacy of Long-term Somatropin Treatment in Children (GrowthWIN II / GrowthWIN II SGA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,442
- 主要终点
- Number of adverse events
研究概览
简要总结
This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In need of somatropin or current user
排除标准
- 未提供
研究组 & 干预措施
Users of somatropin
干预措施: somatropin (Drug)
结局指标
主要结局
Number of adverse events
时间窗: Up to 10 years
次要结局
- Change in height(Up to 10 years)
- Co-morbidities in children small for gestational age(Up to 10 years)
- Onset of puberty in children small for gestational age(Up to 10 years)
- Number of patients continuing somatropin treatment(Up to 10 years)
研究者
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