Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG Somatropin
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 24
- 主要终点
- Ht SDSca
研究概览
简要总结
To evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children with growth hormone deficiency, as well as to study the feasibility of extending the dosing intervals (once per two weeks) of PEG Somatropin Injection.
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
- •Subjects are diagnosed as GHD before starting treatment, according to medical history, clinical symptoms and signs, GH provocation tests and imaging and other examinations:
- •According to statistical height data of physical development of Chinese children in nine cities in 2005, the height is lower than 3rd percentile growth curve of the same age, same sex normal children;
- •Height velocity (HV) ≤5.0 cm / yr;
- •GH provocative tests (with two drugs of different mechanism of action) confirmed plasma GH peak <10.0 ng / ml;
- •bone age for girl≤9 years old, for Boy≤10 years old, bone age is one year or more later than the actual age, that is the actual age - bone age ≥ 1 year;
- •Before puberty (Tanner I stage), age≥3 years old, male or female;
- •Subjects have not received hormone therapy within 6 months;
- •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
- •Dysfunction of liver and kidney (ALT> 2 times the upper limit of normal, Cr> upper limit of normal);
- •Patients positive for hepatitis B c-antibody (HBcAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg);
- •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;
- •Potential cancer patients (family history);
- •Patients with diabetics;
- •Patients with other growth disorders, such as Turner's syndrome, sexual physical delayed puberty, Laron syndrome, growth hormone receptor deficiency, girls with slowly growing who did not rule out chromosomal abnormalities;
- •Patients with congenital bone dysplasia or scoliosis;
- •Subjects took part in other clinical trial study during 3 months;
- •Other conditions in which the investigator preclude enrollment into the study.
研究组 & 干预措施
Jintropin AQ
Jintropin AQ, injection, 30IU/10 mg/3ml/cartridge, 0.25mg/kg/w, once per day for 26 weeks
干预措施: PEG-somatropin (Biological)
PEG-somatropin per two weeks
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks
干预措施: PEG-somatropin (Biological)
PEG-somatropin
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks
干预措施: PEG-somatropin (Biological)
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
- Ht SDSBA(Baseline, 4,12,26 weeks after initiating treatment)
- IGF-1SDS(Baseline, 4,12,26 weeks after initiating treatment)
- IGF-1/IGFBP-3 molar ratio(Baseline, 4,12,26 weeks after initiating treatment)
- Bone age(Baseline, 4,12,26 weeks after initiating treatment)
- Yearly growth velocity(Baseline, 4,12,26 weeks after initiating treatment)