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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
 Jin Soon Hwang  ;  Hae Sang Lee  ;  Kee-Hyoung Lee  ;  Han-Wook Yoo  ;  Dae-Yeol Lee  ;  Byung-Kyu Suh  ;  Cheol Woo Ko  ;  Woo Yeong Chung  ;  Dong-Kyu Jin  ;  Choong Ho Shin  ;  Heon-Seok Han  ;  Song Han  ;  Ho-Seong Kim 
Citation
 HORMONE RESEARCH IN PAEDIATRICS, Vol.90(1) : 54-63, 2018 
Journal Title
 HORMONE RESEARCH IN PAEDIATRICS 
ISSN
 1663-2818 
Issue Date
2018
Keywords
Height velocity ; Idiopathic short stature ; Sustained-release growth hormone
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-naïve, 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.
Files in This Item:
T201803836.pdf Download
DOI
10.1159/000489262
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Ho Seong(김호성) ORCID logo https://orcid.org/0000-0003-1135-099X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/165316
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