Phase Ⅲ Clinical Study of Recombinant Human Growth Hormone Injection (JINTOPIN AQ) for Short Children With Small for Gestational Age(SGA)
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Change of height standard deviation score for chronological age (△Ht SDSCA)
研究概览
简要总结
According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short SGA children, further to evaluate the efficacy and safety of the treatment of short SGA 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
- 24 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of full-term small for gestational age, SGA.
- •Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders.
- •Prepubertal stage (Tanner I).
- •Height was lower than the mean -2SD of the values of normal children of the same age and gender when participating in the study.
- •A GH peak concentration >10µg/L in a provocative test within a year before participating in the study.
- •Bone age<Chronological age+
- •Normal glucose regulation：Fasting blood-glucose < 5.6mmol/L, and 2 hours postprandial blood-glucose < 7.8mmol/L.
- •Gestational age was 37 to 42 weeks.
- •The subjects and their guardians signed informed consent.
排除标准
- •Subjects with Liver and renal insufficiency (ALT > 1.5 times of upper limit of normal value, Cr> upper limit of normal value).
- •Patients are positive for antibodies to hepatitis B core (HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg).
- •Known Highly allergic constitution or allergic to the test drug.
- •Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and hematological diseases, malignant tumors, or systemic infection, immunocompromised patients and patients with psychosis.
- •Subjects with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome and growth hormone receptor deficiency.
- •Subjects who have received the treatment of GH.
- •Subjects took part in other clinical trial study within 3 months.
- •Children who have treated with other hormone (such as gonadal hormone and glucocorticoids etc, continuous administration of more than a month) and that may affect growth hormone secretion or action including oxygen male dragon, growth hormone releasing hormone, etc. within 3 months.
- •Other conditions which in the opinion of the investigator preclude enrollment into the study.
研究组 & 干预措施
Stage 1-experimental group
JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）, for 52 weeks.
干预措施: Recombinant Human Growth Hormone Injection (Drug)
Stage 1-negative control
observed only for 52 weeks.
干预措施: Recombinant Human Growth Hormone Injection (Drug)
Stage 2-experimental group
After completing the stage 1, experimental groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height.
干预措施: Recombinant Human Growth Hormone Injection (Drug)
Stage 2-negative control
After completing the stage 1, negative control groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height.
干预措施: Recombinant Human Growth Hormone Injection (Drug)
结局指标
主要结局
Change of height standard deviation score for chronological age (△Ht SDSCA)
时间窗: 52 weeks
△Ht SDS= Ht SDSafter treatment - Ht SDSbaseline Ht SDSCA = (height - reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint )
次要结局
- Height（Ht）at the end of treatment(Stage 2：Every 52 weeks, up to 3 years)
- Annualized height velocity (HV)(Stage 2：Every 52 weeks, up to 3 years)
- Bone age maturation(Stage 2：Every 52 weeks, up to 3 years)
- Mole ratio of IGF-1 and IGFBP-3(Stage 2：Every 52 weeks, up to 3 years)
- IGF-1 standard deviation score (SDS)(Stage 2：Every 52 weeks, up to 3 years)