NCT03290235Unknown4 期
The Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Ht SDSca (Height standard deviation score for chronological age)
研究概览
简要总结
- To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of children with growth hormone deficiency for a relatively long period
- To explore the factors influencing the efficacy of PEG-Somatropin and to establish the height prediction model based on Chinese children with short stature, and to provide the basis and guidance for standard and reasonable long-term clinical application of PEG-Somatropin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 42 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children has completed all visits and therapy in previous phase IV study;
- •Investigators evaluate subjects could continue growth hormone therapy;
- •Subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.
排除标准
- •Children with epiphyseal closure;
- •Children is near the adule final height, that is, growth rate≤ 2 cm / year or bone age ≥ 14 years old for girls, bone age ≥ 16 years old for boys;
- •Dysfunction of liver and kidney (ALT> 2 times the upper limit of normal, Cr> upper limit of normal);
- •Patients with known hypersensitivity to PEG-Somatropin or Somatropin or any other components of the study product;
- •Patients with severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases;
- •Patients with diabetics;
- •Patients with congenital bone dysplasia or scoliosis;
- •Patients took drugs that would influence the efficacy and safety of PEG-Somatropin after phase IV study and before screening for this extension study;
- •Other conditions in which the investigator preclude enrollment into the study.
研究组 & 干预措施
PEG-somatropin-1
Experimental
Dosage 0.2mg/kg/w
干预措施: PEG-somatropin (Drug)
PEG-somatropin-2
Experimental
Dosage 0.1-0.2mg/kg/w
干预措施: PEG-somatropin (Drug)
结局指标
主要结局
Ht SDSca (Height standard deviation score for chronological age)
时间窗: Baseline, every 13 weeks until 130 weeks
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
- Near final height for some subjects(Baseline, every 13 weeks until 130 weeks)
- IGF-1 SDS (Standard deviation score of insulin-like growth factor-1)(Baseline, every 13 weeks until 130 weeks)
- Ht SDSBA (Height standard deviation score for bone age)(Baseline, every 13 weeks until 130 weeks)
- Bone age(Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks, 130 weeks)
- Yearly growth velocity(Baseline, every 13 weeks until 130 weeks)
研究者
研究点 (1)
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