{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T21:43:33Z","timestamp":1790804613495,"version":"4.1.0"},"reference-count":27,"publisher":"S. Karger AG","issue":"1","license":[{"start":{"date-parts":[[2018,1,1]],"date-time":"2018-01-01T00:00:00Z","timestamp":1514764800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2018,1,1]],"date-time":"2018-01-01T00:00:00Z","timestamp":1514764800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Horm Res Paediatr"],"published-print":{"date-parts":[[2018]]},"abstract":"<b><i>Background\/Aims:<\/i><\/b> To determine the optimal dose of LB03002, a sustained-release, once-weekly formulation of recombinant human growth hormone (rhGH), and to compare its efficacy and safety with daily rhGH in children with idiopathic short stature (ISS). <b><i>Methods:<\/i><\/b> This multicenter, randomized, open-label, phase II study included<b><i><\/i><\/b> GH-na\u00efve, prepubertal children with ISS, randomized to receive daily rhGH 0.37 mg\/kg\/week (control, <i>n<\/i> = 16), LB03002 0.5 mg\/kg\/week (<i>n<\/i> = 14), or LB03002 0.7 mg\/kg\/week (<i>n<\/i> = 16). The primary endpoint was height velocity (HV) change at week 26. <b><i>Results:<\/i><\/b> At week 26, the least square (LS) means for HV change (cm\/year) with control, LB03002 0.5 mg\/kg\/week, and LB03002 0.7 mg\/kg\/week were 5.08, 3.65, and 4.38, and the LS means for the change in height standard deviation score were 0.65, 0.49, and 0.58, respectively. The lower bound of the 90% confidence interval for the difference between LB03002 0.7 mg\/kg\/week and the control in the LS mean for HV change (\u20131.72) satisfied the noninferiority margin (\u20131.75). Adverse events were generally mild and short-lived. <b><i>Conclusion:<\/i><\/b> A once-weekly regimen of LB03002 0.7 mg\/kg demonstrated noninferiority to the daily regimen of rhGH 0.37 mg\/kg\/week in terms of HV increments. LB03002 was well tolerated and its safety profile was comparable with that of daily rhGH.<\/jats:p>","DOI":"10.1159\/000489262","type":"journal-article","created":{"date-parts":[[2018,6,20]],"date-time":"2018-06-20T21:02:05Z","timestamp":1529528525000},"page":"54-63","source":"Crossref","is-referenced-by-count":22,"title":["Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II 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