Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Short Children Born Small for Gestational Age.
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
- 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® in short children born small for gestational age.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronological Age ≥ 4
- •Before the adolescence, Tuner stage I (breast)
- •Height <3rd percentile for age
- •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
- •endocrine and/or metabolic disorders
- •growth failure caused by other disorders
研究组 & 干预措施
DA-3002
1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week).
干预措施: DA-3002 (Drug)
Genotropin®
1.44 IU (0.48mg)/kg/week of Genotropin is injected for 52 weeks by changing injecting areas(six or seven times per week).
干预措施: Genotropin® (Drug)
Non-treatment control group
After no treatment for 26 weeks, 1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(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 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 after 52 weeks(52 weeks)
- Changes in IGFBP-3 after 52 weeks(52 weeks)
- Annualized height velocity(cm/year) after 26 weeks.(26 weeks)
- Changes in height standard deviation score after 52 weeks(52 weeks)
- Changes in bone maturation(changes in bone ages/changes in chronological age) after 52 weeks(52 weeks)