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

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

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4 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1-10
Number of pages10
JournalHormone Research in Paediatrics
DOIs
Publication statusAccepted/In press - 2018 Jun 20

Keywords

  • Height velocity
  • Idiopathic short stature
  • Sustained-release growth hormone

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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    Hwang, J. S., Lee, H. S., Lee, K. H., Yoo, H. W., Lee, D. Y., Suh, B. K., Ko, C. W., Chung, W. Y., Jin, D. K., Shin, C. H., Han, H. S., Han, S., & Kim, H. S. (Accepted/In press). Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II Study. Hormone Research in Paediatrics, 1-10. https://doi.org/10.1159/000489262