2023-506927-27-00招募中3 期
A study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design in children with short stature either born small for gestational age or with Turner syndrome, Noonan syndrome, or idiopathic short stature
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 44
- 主要终点
- Height velocity
研究概览
简要总结
To confirm non-inferiority of once-weekly somapacitan compared with once-daily Norditropin® in terms of longitudinal growth measured by height velocity at week 52 in children with each of the four indications: SGA, TS, NS or ISS.
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
- •No prior exposure to growth promoting therapy, including but not limited to growth hormone, IGF-I and ghrelin analogues.
- •Applicable to children with SGA: Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards). Japan: Please see local requirements in Appendix 11 (Section 10.11).
- •Applicable to children with SGA: Prebubertal Children: a) Boys: - Age above er equal to 2 years and 26 weeks and below 11.0 years at screening. - Testis volume below 4 mL b) Girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. Tanner stage 1 for breast development: No palpable glandular breast tissue
- •Applicable to girls with TS: Confirmed diagnosis of TS: CCI United Kingdom: Please see local requirements in Appendix 11 (Section 10.11).
- •Applicable to girls with TS: Prepubertal girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. - Tanner stage 1 for breast development: No palpable glandular breast tissue)
- •Applicable to children with NS: Clinical diagnosis of NS according to van der Burgt score list (See Table 7) Japan: Please see local requirements in Appendix 11 (Section 10.11).
- •Applicable to children with NS: Prepubertal children: a) Boys: - Age above or equal to 2 years and 26 weeks and below 11.0 years at screening. - Testis volume below 4mL b) Girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. -Tanner stage 1 for breast development: No palpable glandular breast tissue
- •Applicable to children with ISS: Prepubertal children: a) Boys: - Age above or equal to 2 years and 26 weeks and below 11.0 years at screening. - Testis volume below 4mL b) Girls: - Age above or equal to 2 years and 26 weeks and below 10.0 years at screening. -Tanner stage 1 for breast development: No palpable glandular breast tissue
- •Applicable to children with ISS: Bone age: a) Boys: - Bone age below or equal to 12 years. - Bone age not delayed or advanced mor than 2 years compared to chronological age. b) Girls: - Bone age below or equal to 11 years - Bone age not delayed or advanced more than 2 years compared to chronological age.
排除标准
- •Children with suspected or confirmed growth hormone deficiency according to local practice.
- •Children diagnosed with diabetes mellitus or screening values from the central laboratory of a. fasting plasma glucose above or equal to 126 mg/dL (7.0 mmol/L) or b. HbA1c above or equal to 6.5%.
- •Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
结局指标
主要结局
Height velocity
Height velocity
次要结局
- Change in Height SDS
- Change in Height Velocity SDS
- Change in bone age
- Change in IGF-I SDS
- Change in IGFBP-3 SDS
- Change in fasting plasma glucose
- Change in homeostatic model assessment-B (HOMA-B)
- Change in homeostatic model assessment-IR (HOMA-IR)
- Change in glycated haemoglobin (HbA1c)
- CCI
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (44)
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