NCT00455728已完成不适用
International Cooperative Growth Study (iNCGS) Post Marketing Surveillance Program for NutropinAq® [Somatropin (rDNA Origin) Injection]
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 3,690
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect long-term safety and effectiveness information on NutropinAq® during treatment of paediatric growth disorders.
详细描述
The objective of this study is to collect long term safety and effectiveness information on Ipsen's growth hormone (GH) NutropinAq® regarding treatment of paediatric growth disorders for which GH is indicated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Children of either sex who are treated with NutropinAq® for the treatment of growth failure
- •Patients who are willing to comply with follow-up appointments throughout study participation
- •Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable, and by the child when applicable
排除标准
- •Patients not treated with NutropinAq®
- •Patients with closed epiphyses
- •Patients with active neoplasia
结局指标
主要结局
Number of participants with adverse events
时间窗: Every 3 months until study completion
Description and incidence of any Serious Adverse Event (SAE) and all related (serious and non-serious) Adverse Events (AEs).
次要结局
- Treatment height measurements until epiphyseal closure is achieved.(Every 3 months until study completion)
研究者
研究点 (1)
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