NCT01786902已完成3 期
Open, Multi-Center, Controlled, Randomized Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-3002(Recombinant Humn Growth Hormone)Treatment in Children With Idiopathic Short Stature
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Annualized Height Velocity(cm/Year) After 26 Weeks
研究概览
简要总结
Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.
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
- 4 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronological Age ≥ 4
- •Bone Age <11 (for girls) and <13 (for boys)
- •Height <3rd percentile for age
- •normal thyroid function
排除标准
- •endocrine and/or metabolic disorders
- •growth failure caused by other disorders
- •previous use of drugs that could interfere with Growth Hormone treatment
研究组 & 干预措施
DA-3002 Treatment group
Experimental
1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
干预措施: DA-3002 (Drug)
结局指标
主要结局
Annualized Height Velocity(cm/Year) After 26 Weeks
时间窗: 26 weeks
Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.
次要结局
- Changes in Height Standard Deviation Score After 26 Weeks(26 weeks)
研究者
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