NCT01604161已完成不适用
A Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Child Patients With GHD or Turner Short Stature Without Closure of Epiphyseal Discs.
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
- 2,016
- 主要终点
- Change from baseline in height
研究概览
简要总结
This study is conducted in Japan. The aim of this study is to collect information about the efficacy and safety of Norditropin® (somatropin) in the long-term treatment of short stature with GHD (Growth Hormone Deficiency) where epiphysial discs are not closed and short stature with Turner Syndrome where epiphysial discs are not closed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Growth hormone deficiency or short stature due to Turner Syndrome where the epiphyseal discs are not closed
排除标准
- •Patients with malignant tumors
- •Women who are either pregnant or likely to be pregnant
- •Known or suspected allergy to study product(s) or related products
研究组 & 干预措施
Somatropin
干预措施: somatropin (Drug)
结局指标
主要结局
Change from baseline in height
时间窗: Week 0, Month 36, final height is reached
Incidence of adverse reactions (ADRs)
时间窗: 36 months, accumulation of study period
次要结局
未报告次要终点
研究者
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