NCT00190658已完成3 期
Safety and Efficacy of Humatrope in Pediatric Patients With Genetic Short Stature (SHOX Gene Defect)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
研究概览
简要总结
This clinical trial will compare the mean first year height velocity of somatropin-treated prepubertal patients with SHOX deficiency with the height velocity of a control group of untreated prepubertal patients with SHOX deficiency. Both groups will be compared to a somatropin-treated group of girls with Turner syndrome. After the second year patients in the control group have the option to receive treatment as well. All patients will optionally be treated until they achieved adult height.
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
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Turner Syndrome or SHOX disorder
- •SHOX: bone age greater than 10 years for boys, greater than 8 years for girls, Turner: bone age greater than 9 years
- •Height below 3rd percentile or height below 10th percentile and growth velocity below 25th percentile
- •Prepubertal: For girls, Tanner stage 1, for boys Tanner stage 1 and testicular volume no more than 2 mL
排除标准
- •GH deficiency or known insensitivity
- •Evidence of tumor activity
- •Diabetes mellitus or history of impaired glucose tolerance
- •Any severe illness known to interfere growth
结局指标
主要结局
Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
次要结局
- Comparison of second year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
- Non inferiority to somatropin treated patients with Turner syndrome
- Adult height of treated patients
研究者
研究点 (1)
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