NCT01529944已完成3 期
Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Change in height SDS (Standard Deviation Score) (referenced to normal population)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to obtain the PTPN11 mutation status and investigate the impact of the PTPN11 mutation status on the effect of somatropin (Norditropin®) by use of data obtained in the GHNOO-1658 trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the GHNOO-1658 trial
- •Subject has completed genetic testing of PTPN11 mutation
排除标准
- 未提供
研究组 & 干预措施
Low dose 33 mcg/kg/day
Experimental
干预措施: somatropin (Drug)
High dose 66 mcg/kg/day
Experimental
干预措施: somatropin (Drug)
结局指标
主要结局
Change in height SDS (Standard Deviation Score) (referenced to normal population)
时间窗: From baseline until final height is reached
次要结局
- Final height SDS (referenced to normal population)(From baseline until final height is reached)
- Final height SDS (referenced to Noonan population)(From baseline until final height is reached)
- Change in height SDS (referenced to Noonan population)(From baseline until final height is reached)
- Number of subjects with final height SDS above - 2SDS (reference to normal population)(When final height is reached)
- Proportion of subjects with final height SDS above - 2SDS (reference to normal population)(When final height is reached)
- Adverse events(From baseline until final height is reached)
研究者
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