CTIS2022-501055-87-01进行中（未招募）1 期
A study evaluating the safety and efficacy of once-weekly dosing of somapacitan in a basket study design in paediatric participants with short stature either born small of gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature - NN8640-4469
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Applicable to children with SGA - Born small for gestational age (according to national standards)., Applicable to children with TS - Female participants: Age equal to or above xx years and below xx years at screening., Applicable to children with TS - Open epiphyses; defined as bone age xx years for females and bone age xx years for males., Applicable to children with NS - Diagnosis of NS according to local clinical practice., Applicable to children with NS - Male participants: Age equal to or above xx years and below xx years at screening. Female participants: Age equal to or above xx years and below xx years at screening., Applicable to children with NS - Open epiphyses; defined as bone age xx years for females and bone age xx years for males., Applicable to children with ISS - Male participants: Age equal to or above xx years and below xx years at screening. Female participants: Age equal to or above xx years and below xx years at screening., Applicable to children with ISS - Open epiphyses; defined as bone age xx years for females and bone age xx years for males., Applicable to children with SGA - Male participants: Age equal to or above xx years and below xx years at screening. Female participants: Age equal to or above xx years and below xx years at screening., Applicable to children with SGA - Open epiphyses; defined as bone age xx years for females and bone age xx years for males., Applicable to children with TS - Diagnosis of TS according to local clinical practice.
排除标准
- •Children with suspected or confirmed growth hormone deficiency according to local practice., Children diagnosed with diabetes mellitus or screening values from the central laboratory of fasting plasma glucose above or equal to xx, Current inflammatory diseases requiring xx treatment for longer than xx
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