2023-506829-11-00招募中3 期
A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 15
- 主要终点
- Endpoint title: Height velocity Time frame: From baseline (week 0) to visit 7 (week 52) Unit: cm/year
研究概览
简要总结
To compare the effect of somapacitan vs Norditropin® on longitudinal growth in children with growth hormone deficiency
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Prepubertal children: a) Boys: o Age ≥ 2 years and 26 weeks and < 11.0 years at screening o Testis volume < 4 ml b)Girls: o Age ≥ 2 years and 26 weeks and <10.0 years at screening o Tanner stage 1 for breast development (no palpable glandular breast tissue)
- •Confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of ≤ 10.0 ng/ml using the WHO International Somatropin 98/574 standard
- •Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention
- •Impaired height velocity, defined as annualised height velocity below the 25th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening
- •Insulin-like Growth Factor-I < -1.0 Standard Deviation Score at screening, compared to age and gender normalized range measured at central laboratory
- •No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment
排除标准
- •Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
- •Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening
- •Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 µg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
- •Diagnosis of attention deficit hyperactivity disorder
- •Concomitant administration of other treatments that may have an effect on growth, e.g but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder
- •Prior history or presence of malignancy including intracranial tumours
结局指标
主要结局
Endpoint title: Height velocity Time frame: From baseline (week 0) to visit 7 (week 52) Unit: cm/year
Endpoint title: Height velocity Time frame: From baseline (week 0) to visit 7 (week 52) Unit: cm/year
次要结局
- Effect Endpoint title: Change in bone age Time frame: From screening (visit 1) to visit 7 (week 52) Unit: Years
- Effect Endpoint title: Change in Height Standard Deviation Score Time frame: From baseline (week 0) to visit 7 (week 52) Unit: -10 to +10
- Effect Endpoint title: Change in Height Velocity SDS Time frame: From baseline (week 0) to visit 7 (week 52) Unit: -10 to +10
- Safety Endpoint title: Change in fasting plasma glucose Time frame: From screening (visit 1) to visit 7 (week 52) From screening (visit 1) to visit 11 (week 104) From screening (visit 1) to visit 15 (week 156) From screening (visit 1) to visit 19 (week 208) Unit: mmol/L
- Safety Endpoint title: Change in homeostatic model assessment (HOMA) Time frame: From screening (visit 1) to visit 7 (week 52) From screening (visit 1) to visit 11 (week 104) From screening (visit 1) to visit 15 (week 156) From screening (visit 1) to visit 19 (week 208) Unit: %
- Safety Endpoint title: Change in Glycated haemoglobin (HbA1c) Time frame: From screening (visit 1) to visit 7 (week 52) From screening (visit 1) to visit 11 (week 104) From screening (visit 1) to visit 15 (week 156) From screening (visit 1) to visit 19 (week 208) Unit: % point
- Pharmacodynamics Endpoint title: Change in IGF-I SDS Time frame: From baseline (week 0) to visit 7 (week 52) From baseline (week 0) to visit 11 (week 104) From baseline (week 0) to visit 15 (week 156) From baseline (week 0) to visit 19 (week 208) Unit: -10 to +10
- Pharmacodynamics Endpoint title: Change in IGFBP-3 SDS Time frame: From baseline (week 0) to visit 7 (week 52) From baseline (week 0) to visit 11 (week 104) From baseline (week 0) to visit 15 (week 156) From baseline (week 0) to visit 19 (week 208) Unit: -10 to +10
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (15)
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