NCT02380235Unknown4 期
Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 12
- 主要终点
- Ht SDSca
研究概览
简要总结
This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of 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, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.
- •According to the height statistical data of Chinese children's physique development in nine cities in 2005,height is lower than the third percentile of growth curve of normal children with the same age and gender.
- •Height velocity (HV) ≤5.0 cm/yr.
- •GH stimulation test with two different mechanisms affirms that GH peak concentration of patients' plasma<10.0ng/ml.
- •Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than his/her chronological age (CA).
- •Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.
- •Receive no prior GH treatment within 6 months.
- •Sign informed consent.
排除标准
- •People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal value, Cr> the upper limit of normal value).
- •Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis Be antigen (HBeAg).
- •People with known highly allergic constitution or allergy to the drug of the study.
- •People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency.
- •Diabetic.
- •Potential tumor patients (family history).
- •Abnormal growth and development, such as Turner syndrome, constitutional delay of growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome.
- •Subjects took part in other clinical trial study within 3 months.
- •Other conditions which in the opinion of the investigator preclude enrollment into the study.
结局指标
主要结局
Ht SDSca
时间窗: Baseline, 4,12,26 weeks after initiating treatment
Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age
次要结局
未报告次要终点
研究者
研究点 (12)
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