NCT00184756已完成3 期
Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 38
- 主要终点
- Evaluate effect on Height in SGA Children Treated with Growth Hormone
研究概览
简要总结
This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references.
- •Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion
排除标准
- •Growth Hormone Deficiency (GHD)
- •Treatment with any medical product which may interfere with GH effects
- •Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders
结局指标
主要结局
Evaluate effect on Height in SGA Children Treated with Growth Hormone
时间窗: After 2 years of treatment
次要结局
- Appetite
- Height SDS, yearly
研究者
研究点 (38)
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