Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient：A Multicenter, Randomized, Open-label, Controlled Phase Ⅲ Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 6
- 主要终点
- yearly growth velocity
研究概览
简要总结
This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation).
All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study.
Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.
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
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Subjects have a height less than two standard deviations (SD) below the median height for individuals of he same age or height,the growth velocity (CV≤4.0 cm/yr),GH peak concentration <7.0ng/ml in two difference provocative tests, Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 2 year less than his/her chronological age (CA)
- •be in preadolescence (Tanner stage 1) and have a CA > 3 years
- •have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV.
- •receive no prior GH treatment.
- •sign informed consent
排除标准
- •1. patients positive for hepatitis B e-antibody (HBeAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)
- •2.Known hypersensitivity to Somatropin or any other components of the study product.
- •3. severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases
- •4. with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome
- •5. Subjects took part in other clinical trial study during 3 months.
- •6. Other conditions which in the opinion of the investigator preclude enrollment into the study.
结局指标
主要结局
yearly growth velocity
时间窗: 6 months
growth velocity add as GV was the primary outcome measure
次要结局
- IGF-l(6 months)
- Ht SDSca(6 months)
- IGFBP-3(6 months)
- bone maturity(6 months)