A Multicenter, Randomized, Open-Label, Active-Controlled, Non-Inferiority Phase 3 Study to Evaluate the Efficacy and Safety of Human Growth Hormone Injection (Sinotropin AQ) for the Treatment of Children With Idiopathic Short Stature (ISS)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 34
- 主要终点
- The value of Annual Height velocity
研究概览
简要总结
This study is a multicenter, randomized, open-label, active-controlled, non-inferiority Phase III clinical trial. It aims to evaluate the efficacy and safety of Human Growth Hormone (hGH) Injection (Sinotropin AQ) in pediatric participants with Idiopathic Short Stature (ISS). Eligible participants will be randomized to receive either the study drug or an active comparator for 52 weeks. The primary efficacy endpoint is height velocity (HV, cm/year) over the treatment period. The study drug will be administered subcutaneously once daily at a dose of 0.15 IU/kg. The results of this trial will provide evidence on whether hGH Injection represents an effective and safe treatment option for improving height in children with ISS.
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
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Tanner stage I (prepubertal) at informed consent: males aged 3 to <11 years ; females aged 3 to <10 years ;
- •2. At screening, height < -2 standard deviations (SD) for age and sex (height reference per Appendix 1);
- •3. Peak GH ≥10.0 ng/mL in any growth hormone (GH) stimulation test;
- •4. Bone age minus chronological age ≤ 1 year.
排除标准
- •1.Closed epiphyses (skeletally mature)；
- •2.Severe allergic diathesis, or known hypersensitivity to growth hormone or any of its excipients；
- •3.History of malignancy or current active malignancy；
- •4.Systemic chronic diseases, including but not limited to moderate-to-severe anemia, hypothyroidism, chronic kidney disease, cardiovascular disease (e.g., dilated cardiomyopathy), psychiatric disorders, or congenital anomalies that require clinical intervention per the investigator's judgment.
- •5.Patients with a prior diagnosis of intracranial hypertension;
- •6.Patients with congenital skeletal dysplasia, or scoliosis ≥15° (or moderate or greater), limping (gait disturbance), and patients with a prior diagnosis of slipped capital femoral epiphysis ;
- •7.Other types of growth and developmental disorders, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, small for gestational age (SGA), short stature due to SHOX gene defects, and short stature of other identified causes;
- •8. Patients with a confirmed diagnosis of diabetes mellitus, or fasting blood glucose ≥6.1 mmol/L on two consecutive measurements.
研究组 & 干预措施
Human growth hormone Injection（Investigational product）
This product is human growth hormone (hGH) injection (Sinotropin AQ). Usage and dosage: 0.15 IU/kg/day (0.05 mg/kg/day), once daily, administered by subcutaneous injection.
干预措施: Human Growth Hormone (hGH) (Drug)
human growth hormone（hGH） injection（reference product）
This product is human growth hormone (hGH) injection. Usage and dosage: 0.15 IU/kg/day (0.05 mg/kg/day), once daily, administered by subcutaneous injection.
干预措施: Human Growth Hormone (hGH) (Drug)
结局指标
主要结局
The value of Annual Height velocity
时间窗: At the end of 52 weeks of treatment
The value of Annual Height velocity (HV, cm/year)
次要结局
- The change of ΔHT SDS value(At all visit points from baseline to week 52)
- The change of IGF-1 SDS value(At all visit points from baseline to Week 52)
- The change of height velocity value (ΔHV)(At all visit points from baseline to Week 52)
- The change of bone age relative to change of chronological age(ΔBA/ΔCA) value(At all visit points from basline to week 52)
- The safety of human growth hormone injection(Baseline, Week 13, Week 26, Week 39, and Week 52)
- Immunogenicity of Human Growth Hormone Injection(At all visit points from baseline to week 52)