NCT03635580Unknown3 期
Phase 2 Study of Efficacy and Safety of rhGH (Jintropin®) in Pediatric Participants With ISS (Idiopathic Short Stature): a 52-week Multicenter, Open-label, Randomized, Negative Controlled Study Followed by a 52-week Open-label Period
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 480
- 试验地点
- 9
- 主要终点
- ΔHtSDSca (The change of height standard deviation score of chronological age before and after treatment)
研究概览
简要总结
Phase 1: To evaluate the safety and efficacy of 0.05mg/kg/d of rhGH (Jintropin®) in the treatment of children with idiopathic short stature (ISS) in 52 weeks.
Phase 2: To evaluate the safety and efficacy of rhGH (Jintropin®) in the treatment of children with ISS in 2 years
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
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys are between 4 and 10 years old age and girls are between 4 and 9 years old age;
- •Height <-2.25 SD (Standard deviation) for chronological age;
- •GH (Growth hormone) peak concentration ≥10.0 ng/mL in GH stimulation tests;
- •The bone age (BA) ≤chronological age (CA)+6 months;
- •Prepubertal Status (Tanner Stage I);
- •Birth weight within the normal range;
- •Growth hormone treatment-naive;
- •Participants are 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
- •Participants with abnormal liver and kidney functions (ALT > upper limit 1.5 times of normal value; Cr > upper limit of normal value);
- •Participants are positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests;
- •Participants with known highly allergic constitution or allergy to investigational product or its excipient;
- •Participants with systemic chronic disease and immune deficiency;
- •Participants diagnosed with tumor, or with potential high tumor risks such as tumor markers exceed normal range and some other relative information may be excluded from the treatment;
- •Participants with mental disease;
- •Participants with other types of abnormal growth and development;
- •Growth hormone deficiency (GHD) (confirmed by GH stimulation test);
- •Turner syndrome (confirmed by karyotype test of girls);
- •Noonan syndrome (hypertelorism, pectus carinatum, hypophrenia, frequently with skin disease and congenital heart disease, missense mutation of the protein tyrosine phosphatase, non-receptor type 11 (PTPN11) gene on chromosome 12 for half of the participants, for both male and female participants);
- •Laron syndrome (confirmed by IGF-1 generation test);
- •Small for gestational age ( the birth height or weight is below the tenth percentile or 2 SD, with catch-up growth uncompleted at 2 years old);
- •Growth disorders caused by malnutrition or hypothyroidism (thyroid function test).
- •Participants with impaired glucose regulation (IGR) (including impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) ) or diabetes;
- •BMI (Body mass index) ≥22kg/m²;
- •Congenital skeletal abnormalities or scoliosis, claudication;
- •Participants who took part in other clinical trials within 3 months;
- •Participants who received medications which may interfere GH secretion or GH function, or other hormones within 3 months (such as sex steroids, glucocorticoids, etc.);
- •Other conditions which is inappropriate for this study in the opinion of the investigator.
研究组 & 干预措施
rhGH/Jintropin AQ
Experimental
Jintropin AQ, injection, 30IU/10mg/3ml/cartridge, 0.05mg /kg/d in phase 1 and 0.05-0.07mg/kg/d in phase 2.
干预措施: Negative control (Other)
结局指标
主要结局
ΔHtSDSca (The change of height standard deviation score of chronological age before and after treatment)
时间窗: Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
ΔHtSDSca was the difference of HtSDSca before and after treatment, and HtSDSca 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
- Yearly growth velocity(Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.)
- ΔIGF-1 SDS (Change of insulin-like growth factor 1 standard deviation score)(Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.)
- ΔHT (Change of height)(Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.)
- △BA/CA (bone age change / chronological age)(Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.)
研究者
研究点 (9)
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