NCT04513171已完成2 期
A Multi-center, Randomized, Positive-control, Phase 2&3 Combined Study of Y-shape Pegylated Somatropin in Prepubertal Children With Growth Hormone Deficiency.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- Phase 2: Change of areas under the curve of IGF-1 concentration from baseline (ΔIGF-1 AUC).
研究概览
简要总结
This is a multicenter, randomized, open-labeled, positive controlled phase 2&3 combined study to evaluate the safety and efficacy of weekly Y-shape pegylated somatropin, compared to daily somatropin (Norditropin®), in prepubertal, treatment-naive children with growth hormone deficiency.
详细描述
This multicenter, randomized, open-labeled, positive controlled study is divided into two stages. The first one is aimed to exploit the optimal dose of Y-shape pegylated somatropin, while the second one is aimed to confirm the efficacy and safety of the study drug. A total of 400 prepubertal children with growth hormone deficiency were expected to enrolled. Subjects will firstly undergo a 52 weeks treatment, and then followed for 5 weeks.
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 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of GHD confirmed by two different GH stimulation tests, defined as a peak of GH level of <10.0 ng/ml, determined with a validated assay. Bone age (BA) at least 2 years less than the chronological age. Growth velocity less than 5.0 cm/year. Impaired HT defined as at least 2.0 standard deviations (SD) below of the mean height for chronological age and sex (HT SDS<-2.0).
- •Prepubertal (Tanner Ⅰ) males and females by physical examination, aged older than 3 years and younger than10 years for girls and 11 years for boys.
- •Short stature with normal intelligence.
- •Baseline IGF-1 level below the median IGF-1 level standardized for age and sex.
- •Written, signed informed consent of the parent(s) or legal guardian(s) of the subject and written assent of the subject (if the subject is 8 years old or above).
排除标准
- •Prior exposure to growth promotion treatment, such as recombinant human growth hormone or gonadal hormones, for more than 1 month.
- •Known hypersensitivity to somatropin or excipients, such as mannitol, lysine, sodium chloride.
- •Children with closed epiphyses.
- •Short stature etiologies other than GHD, such as idiopathic short stature, Turner syndrome, Prader-Willi syndrome, Russell-Silver syndrome, born small for gestational age regardless of GH status.
- •Other causes of short stature such as hypothyroidism, adrenocortical hormone deficiency, antidiuretic hormone deficiency.
- •Any medical conditions and/or presence that may affect growth velocity such as liver dysfunction, kidney dysfunction, malnutrition, diabetes mellitus, severe dysfunction in major organ such as heart, sever systemic infections, severe immune dysfunction, mental disorders, and other congenital malformations.
- •Suffering from chronic infectious diseases such as chronic hepatitis B, AIDS or tuberculosis.
- •Receiving non-physiological adrenal corticosteroids.
- •Confirmed pituitary and/or hypothalamic malignance by MRI within one year prior to screening. History or presence of any other malignance disease, any evidence of present tumor growth.
- •Evidence of congenital intracranial hypertension.
- •Evidence of slipped capital femoral epiphysis.
- •Evidence of scoliosis over 15°.
- •Participation in any other trial of an investigational agent within 3 months prior to screening.
- •Any other conditions which in the opinion of the investigator precluded enrollment into the study.
研究组 & 干预措施
Norditropin-1
Active Comparator
干预措施: Norditropin® (Drug)
Y-shape pegylated somatropin low dose
Experimental
干预措施: Y-shape pegylated somatropin (Drug)
Y-shape pegylated somatropin middle dose
Experimental
干预措施: Y-shape pegylated somatropin (Drug)
Y-shape pegylated somatropin high dose
Experimental
干预措施: Y-shape pegylated somatropin (Drug)
Y-shape pegylated somatropin optimal dose
Experimental
干预措施: Y-shape pegylated somatropin (Drug)
Norditropin-2
Active Comparator
干预措施: Norditropin (Drug)
结局指标
主要结局
Phase 2: Change of areas under the curve of IGF-1 concentration from baseline (ΔIGF-1 AUC).
时间窗: 12 weeks
Phase 3: Height velocity.
时间窗: 52 weeks
次要结局
- Serum IGFBP-3 level(change from baseline to 52 weeks)
- Change of height standard deviation score according to chronological age.(52 weeks)
- Change of height standard deviation score according to bone age.(52 weeks)
- Serum IGF-l level(change from baseline to 52 weeks)
研究者
研究点 (1)
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