NCT01734486已完成4 期
Growth Response in Girls With Turner Syndrome During a Three-year GH Treatment Comparing Two Dose Regimens. Identification of Predictive Factors of Growth Response
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Height gain in cm
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to evaluate growth response of two somatropin dose regimens in girls with Turner Syndrome.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Turner syndrome
- •If age below 3 years, either body height below - 1 SD (standard deviation) with average growth velocity according to chronological age or body height below 0 SD with growth velocity below -1 SD according to chronological age
- •If age above 3 years, body height below - 1 SD with average growth velocity according to chronological age
- •Measured parental height available
- •Written informed consent
排除标准
- 未提供
研究组 & 干预措施
Low dose
Experimental
干预措施: somatropin (Drug)
High dose
Experimental
干预措施: somatropin (Drug)
结局指标
主要结局
Height gain in cm
Height gain, SDS (Standard Deviation Score)
次要结局
- Bone maturation
- Height
研究者
研究点 (1)
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