NCT06309979招募中不适用
A Multicenter, Observational Study to Characterize Growth in Children With Idiopathic Short Stature
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 77
- 主要终点
- Change in BMI
研究概览
简要总结
Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be > 2 years old, and ≤ 14 years old (female) or ≤ 16 years old (males) at the time of signing the informed consent.
- •A height assessment corresponding to a height Z-score of ≤ -2.25 SDs in reference to the general population of the same age and sex, as calculated using the Centers for Disease Control and Prevention (CDC) growth chart (https://www.cdc.gov/growthcharts/zscore.htm).
- •Participants who have either never received hGH, or who are currently receiving hGH treatment.
- •Historic stimulation test result with serum or plasma GH level greater than 10 μg/L.
- •Parent(s) or guardian(s) are willing and able to provide written, signed informed consent.
排除标准
- •Diagnosis of systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic and metabolic disease. Children with such diagnoses can be considered for inclusion if their condition is well controlled, at the discretion of the Medical Monitor.
- •Known presence of one or more pituitary hormone deficiencies
- •Bone age advanced over chronological age by more than 3 years.
- •For hGH naïve participants, historic stimulation test result with serum or plasma GH level greater than 10 μg/L or serum IGF-1 in the normal range for age (between -1.00 SDs and +2.00 SDs).
- •For participants currently on hGH treatment, historic results before GH treatment of stimulation test with serum or plasma GH level greater than 10 μg/L or serum IGF-1 test between -1.00 SDs and +2.00 SDs.
- •Have received an investigational product (IP) or investigational medical device for any purpose within 6 months before the Screening visit. .
结局指标
主要结局
Change in BMI
时间窗: Every 6 months through end of study, up to 15 years
Change in annualized growth velocity (AGV)
时间窗: Every 6 months through end of study, up to 15 years
Change in BMI Z-score
时间窗: Every 6 months through end of study, up to 15 years
Change in Standing Height
时间窗: Every 6 months through end of study, up to 15 years
Change in Height Z-score
时间窗: Every 6 months through end of study, up to 15 years
次要结局
- Frequency of Serious Medical Events(Every 6 months through end of study, up to 15 years)
- Association between specific variants and growth velocity(Every 6 months through end of study, up to 15 years)
- Association between other health outcomes directly related to short stature(Every 6 months through end of study, up to 15 years)
- Frequency of event rates of medical events of interest(Every 6 months through end of study, up to 15 years)
研究者
研究点 (77)
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