NCT02908958Unknown4 期
Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial II
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 900
- 试验地点
- 22
- 主要终点
- The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA)
研究概览
简要总结
To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Before starting treatment, the child is diagnosed as GHD according to medical history,clinical symptoms and signs, GH provocation tests and imaging examinators and other examinators.
- •According to the height statistical data of Chinese children's physical development in nine cities in 2015, the height of the child is lower than the third percentile of normal children's growth curve in the same age and same gender.
- •Height velocity (HV) ≤5.0 cm/yr.
- •GH provocation tests with two different mechanisms showed that GH peak concentration of the child is < 10.0ng/ml.
- •Bone age (BA) ≤9 years in girls or ≤ 10 years in boys, and the BA is 1 year less than the CA.
- •Prepuberty status (Tanner I stage), age ≥3 years old, girls and boys are acceptable.
- •The child did not receive the treatment of growth hormone within 6 months.
- •Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, and they sign informed consent.
排除标准
- •The child is dysfunction of liver and kidney (ALT) 2 times of the upper limit of normal value, Cr> the upper limit of normal value).
- •The child has positive hepatitis B core antibody (HBc), hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg).
- •The child is known as hypersensitivity to PEG Somatropin.
- •The child has severe cardiopulmonary, hematological diseases, malignant tumors, general infection or immunodeficiency diseases.
- •The child has potential tumor (family history).
- •The child has diabetics.
- •The child has abnormal growth and development, such as Turner's syndrome, constitutional delay of growth and puberty, Laron syndrome, growth hormone receptor deficiency, short stature girls with potential chromosomal abnormalities.
- •The child took part in other clinical trials within 3 months.
- •Other conditions are excluded when the investigator preclude the enrollment into the study.
研究组 & 干预措施
PEG-somatropin
Experimental
Low dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
干预措施: PEG-somatropin (Biological)
PEG-Somatropin
Experimental
High dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
干预措施: PEG-somatropin (Biological)
结局指标
主要结局
The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA)
时间窗: 26 weeks
HtSDSCA = (Height at the evaluated time point- the mean value of normal children in the same gender and same age) / the height SD of normal children in the same gender and same age
次要结局
- HtSDSBA(26 weeks)
- Bone Maturation(26 weeks)
- Annual height velocity(26 weeks)
- Standard Deviation Score of serum IGF-1 (IGF-1 SDS)(26 weeks)
研究者
研究点 (22)
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