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ey0020.2-11 | Long-Acting Growth Hormone (LAGH) | ESPEYB20

2.11. Somapacitan in children born small for gestational age: a multi-centre, open-label, controlled phase 2 study

A Juul , P Backeljauw , M Hojby , M Kawai , RJ Kildemoes , A Linglart , N Zuckerman-Levin , R Horikawa

Brief summary: This is the first multi-national phase 2 dose finding trial aimed at investigating efficacy and safety of the long acting GH (Somapacitan) with daily GH in short children born SGA. 62 GH treatment-naïve short children born SGA were enrolled in the study. Efficacy was valuated with estimated mean annualized height velocity (HV) after 26 weeks of follow-up. Somapacitan showed similar efficacy of daily rhGH. The study will be extended for further 4 years in or...

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ey0018.4-5 | Growth Hormone Therapy: Safety | ESPEYB18

4.5. Long-term safety of growth hormone treatment in childhood: two Large observational studies: nordiNet IOS and ANSWER

L Savendahl , M Polak , P Backeljauw , JC Blair , BS Miller , TR Rohrer , A Hokken-Koelega , A Pietropoli , N Kelepouris , J Ross

J Clin Endocrinol Metab. 2021 May 13;106(6):17281741. doi: 10.1210/clinem/dgab080. PMID: 33571362This report gathered data from two large observational studies (NordiNet International Outcome Study and ANSWER Program) aimed at assessing the incidence of adverse drug reactions (ADRs), serious adverse events (SAEs), and their relation with rhGH dose. The whole study cohort included 37,7...

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ESPE Yearbook of Paediatric Endocrinology

2.11. Somapacitan in children born small for gestational age: a multi-centre, open-label, controlled phase 2 study

4.5. Long-term safety of growth hormone treatment in childhood: two Large observational studies: nordiNet IOS and ANSWER

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