NCT03221933已完成2 期
Phase Ⅱ Clinical Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for Gestational Age(SGA)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Height standard deviation score for chronological age (Ht SDSCA)
研究概览
简要总结
To preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose.
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
- Single (Participant)
入排标准
- 年龄范围
- 24 Months 至 90 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of small for gestational age, SGA.
- •Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders.
- •Prepubertal stage (Tanner I).
- •Without catch-up growth in two years after birth.
- •Height was lower than the mean -2SD of the values of normal children of the same age and gender when participating in the study.
- •A GH peak concentration >10µg/L in a provocative test within a year before participate in the study.
- •Bone age<Chronological age+
- •Normal glucose regulation：Fasting blood-glucose < 5.6mmol/L and 2-hour postprandial blood glucose< 7.8mmol/L.
- •Gestational age≥Gestational age≥ 36weeks + 4days.
- •Never accepted growth hormone treatment.
- •The subjects and their guardians signed informed consent.
排除标准
- •Subjects with Liver and renal insufficiency (ALT > 2 times of upper limit of normal value, Cr> upper limit of normal value).
- •Patients with positive for antibodies to hepatitis B core (anti-HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)。
- •Known highly allergic constitution or allergic to the test drug.
- •Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and hematological diseases, malignant tumors, or systemic infection, immunocompromised patients and patients with psychosis.
- •Subjects with other types of abnormal growth and development, such as Turner syndrome, constitutional delay of puberty, Laron syndrome, growth hormone receptor deficiency.
- •Subjects who have received the treatment of Somatropin or took part in other clinical trial study within 3 months.
- •Other conditions which in the opinion of the investigator preclude enrollment into the study.
研究组 & 干预措施
Somatropin Injection low dose group
Experimental
0.23mg/kg /wk，inject for seven divided doses.
干预措施: Somatropin Injection low dose group (Biological)
Somatropin Injection low dose group
Experimental
0.23mg/kg /wk，inject for seven divided doses.
干预措施: Somatropin Injection high dose group (Biological)
Somatropin Injection high dose group
Experimental
0.46mg/kg /wk，inject for seven divided doses.
干预措施: Somatropin Injection low dose group (Biological)
Somatropin Injection high dose group
Experimental
0.46mg/kg /wk，inject for seven divided doses.
干预措施: Somatropin Injection high dose group (Biological)
结局指标
主要结局
Height standard deviation score for chronological age (Ht SDSCA)
时间窗: 104 weeks
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
次要结局
- Change in obesity prevalence(26 weeks， 52 weeks，78 weeks and 104 weeks)
- Change in overweight(26 weeks， 52 weeks，78 weeks and 104 weeks)
- Change in bone age maturation(26 weeks， 52 weeks，78 weeks and 104 weeks)
- Change in PAH(26 weeks， 52 weeks，78 weeks and 104 weeks)
- Change in HV(26 weeks， 52 weeks，78 weeks and 104 weeks)
- Change in mole ratio of IGF-1 and IGFBP-3(26 weeks， 52 weeks，78 weeks and 104 weeks)
- ΔHtSDSCA(26 weeks， 52 weeks，78 weeks and 104 weeks)
研究者
研究点 (5)
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