NCT00452725已完成3 期
Effect of the Growth Hormone MAXOMAT ® on the Growth of Small Children and Adolescents (<-2 SD) Due to NOONAN's Syndrome
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Evaluation of height : gain in height and rate of growth
研究概览
简要总结
- Clinical Objective : To improve the growth of these children
- Genetic objective : A study of the genetics of the syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents with Noonan's syndrome with a height < -2 SD and no progressive cardiopathy
排除标准
- •Age < 3 years
- •Height ≥ -2 SD
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Evaluation of height : gain in height and rate of growth
时间窗: at each visit (every 3 months) or every 6 months
次要结局
- Clinical and laboratory test safety(every 6 months)
研究者
研究点 (1)
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