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Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II Study

Authors
Hwang, Jin SoonLee, Hae SangLee, Kee-HyoungYoo, Han-WookLee, Dae-YeolSuh, Byung-KyuKo, Cheol WooChung, Woo YeongJin, Dong-KyuShin, Choong HoHan, Heon-SeokHan, SongKim, Ho-Seong
Issue Date
2018
Publisher
KARGER
Keywords
Sustained-release growth hormone; Idiopathic short stature; Height velocity
Citation
HORMONE RESEARCH IN PAEDIATRICS, v.90, no.1, pp.54 - 63
Indexed
SCIE
SCOPUS
Journal Title
HORMONE RESEARCH IN PAEDIATRICS
Volume
90
Number
1
Start Page
54
End Page
63
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/81077
DOI
10.1159/000489262
ISSN
1663-2818
Abstract
Background/Aims: 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). Methods: This multicenter, randomized, open-label, phase II study included GH-naive, prepubertal children with ISS, randomized to receive daily rhGH 0.37 mg/kg/week (control, n = 16), LB03002 0.5 mg/kg/week n = 14), or LB03002 0.7 mg/kg/week (n = 16). The primary endpoint was height velocity (HV) change at week 26. Results: 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 (-1.72) satisfied the noninferiority margin (-1.75). Adverse events were generally mild and short-lived. Conclusion: 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. (C) 2018 The Author(s) Published by S. Karger AG, Basel
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