A Phase II, Multi-center, Randomized, Comparative, Parallel, Open, Dose Finding Study to Assess the Efficacy and Safety After 26 Week-treatment of Eutropin Plus (SR-hGH) Compared to Eutropin Inj. in Pre-pubertal Children With Idiopathic Short Stature
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change from baseline in height velocity at Week 26, cm/year
研究概览
简要总结
The purpose of this study is to assess dosing requirements and establish the efficacy of SR-hGH in idiopathic short stature patients (ISS). This phase II study is designed as multi-center, randomized, active comparator-controlled, parallel, open-label.
45 patients were randomized to three arms with 1:1:1 ratio, two arms of Sr-hGH and one of daily hGH. Two doses of Sr-hGH were administered, which are 0.5 and 0.7mg/kg/week. And the other arm received daily hGH at 0.37 mg/kg/week.
Patients in Sr-hGH groups injected on a specific day of the every week for 26 weeks. And patients randomized to daily hGH group injected for 6 days a week.
Patients visited study centers five times, firstly at screening (Visit 1), at randomization (Visit 2), after 13th dosing (Visit 3), after 26th dosing (Visit 4), and finally for follow-up (Visit5).
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 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sr-hGH 0.5 mg/kg/wk
Patients inject Eutropin plus (Sr-hGH) 0.5 mg/kg/wk every week himself/herself.
干预措施: human growth hormone self-injection (Drug)
Sr-hGH 0.7 mg/kg/wk
Patients inject Eutropin plus (Sr-hGH) 0.7 mg/kg/wk every week himself/herself.
干预措施: human growth hormone self-injection (Drug)
Daily hGH 0.37 mg/kg/wk
Patients inject Eutropin (daily hGH) 0.37 mg/kg/wk everyday for the first 6days a week himself/herself.
干预措施: human growth hormone self-injection (Drug)
结局指标
主要结局
Change from baseline in height velocity at Week 26, cm/year
时间窗: Week 0-26
次要结局
- Change from baseline in height velocity, cm/year(at Week 13)
- Change from baseline in height, cm(at Week 13 and 26)
- Change from baseline in IGF (Insulin-like growth factor)-I and IGF-I SDS (standard deviation score)(at Week 13 and 26)