NCT01813630已完成3 期
Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Patients With Turner's Syndrome
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
- 58
- 试验地点
- 1
- 主要终点
- Annualized height velocity(cm/year) after 52 weeks
研究概览
简要总结
A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.
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
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Turner's Syndrome through chromosome analysis
- •The chronological age: 2≤AGE≤12
- •The yearly growth rate should be less than 6cm; the bone age should be equal or less than 12; the height ≤ 10th percentile for the heights of their agemates
- •Before the adolescence, Tuner stage I (breast)
- •Normal thyroid function
排除标准
- •Growth hormone was administered for 12 months or longer in the past
- •Treated with estrogen or adrenal androgens for 12 months or longer in the past
- •Malignancy, CNS Trauma, Psychiatric Disorder
研究组 & 干预措施
DA-3002
Experimental
0.14 IU (0.045-0.050mg)/kg/day of DA-3002 is injected for 52 weeks by changing injecting areas
干预措施: DA-3002 (Drug)
Genotropin®
Active Comparator
0.14 IU (0.045-0.050mg)/kg/day of Genotropin is injected for 52 weeks by changing injecting areas
干预措施: Genotropin® (Drug)
结局指标
主要结局
Annualized height velocity(cm/year) after 52 weeks
时间窗: 52 weeks
Height velocity calculated with height measured at Baseline and after 52 weeks was converted to annual growth rate
次要结局
- Changes in IGF-1(52 weeks)
- Changes in height standard deviation score after 52 weeks(52 weeks)
- Changes in bone maturation(changes in bone ages/changes in chronological age)(52 weeks)
- Changes in IGFBP-3(52 weeks)
研究者
研究点 (1)
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