A dose-finding trial evaluating the effect and safety of once-weekly treatment of somapacitan compared to daily Norditropin® in children with short stature born small for gestational age with no catch-up growth by 2 years of age or older - NN8640-4245

ovo Nordisk A/S0 个研究点目标入组 62 人开始时间: 2024年3月22日最近更新: 2024年7月22日

研究概览

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•Prepubertal children: a)Boys: oAge = 2 years and 26 weeks and < 11.0 years at screening o Testis volume < 4 ml b)Girls: oAge = 2 years and 26 weeks and <10.0 years at screening oTanner stage 1 for breast development (no palpable glandular breast tissue), Born small for gestational age (birth length and/or weight < -2 standard deviation scores) (according to national standards)., Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and gender at screening according to the standards of Centers for Disease Control and Prevention at screening., Impaired height velocity defined as annualised height velocity below the 50th 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., No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment.

•Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements., Children with hormonal deficiencies including suspected or confirmed growth hormone deficiency according to local practise., 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., 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., Diagnosis of attention deficit hyperactivity disorder., Prior history or presence of malignancy including intracranial tumours.

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