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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

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dc.contributor.authorHwang, JS-
dc.contributor.authorLee, HS-
dc.contributor.authorLee, KH-
dc.contributor.authorYoo, HW-
dc.contributor.authorLee, DY-
dc.contributor.authorSuh, BK-
dc.contributor.authorKo, CW-
dc.contributor.authorChung, WY-
dc.contributor.authorJin, DK-
dc.contributor.authorShin, CH-
dc.contributor.authorHan, HS-
dc.contributor.authorHan, S-
dc.contributor.authorKim, HS-
dc.date.accessioned2019-11-13T00:20:13Z-
dc.date.available2019-11-13T00:20:13Z-
dc.date.issued2018-
dc.identifier.issn1663-2818-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/17220-
dc.description.abstractBACKGROUND/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.
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dc.language.isoen-
dc.subject.MESHBody Height/drug effects-
dc.subject.MESHChild-
dc.subject.MESHChild, Preschool-
dc.subject.MESHDelayed-Action Preparations/administration & dosage-
dc.subject.MESHFemale-
dc.subject.MESHGrowth Disorders/drug therapy-
dc.subject.MESHGrowth Disorders/pathology-
dc.subject.MESHGrowth Disorders/physiopathology-
dc.subject.MESHHuman Growth Hormone/administration & dosage-
dc.subject.MESHHumans-
dc.subject.MESHMale-
dc.subject.MESHRepublic of Korea-
dc.titleOnce-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II Study-
dc.typeArticle-
dc.identifier.pmid29925064-
dc.identifier.urlhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6172795/-
dc.subject.keywordSustained-release growth hormone-
dc.subject.keywordIdiopathic short stature-
dc.subject.keywordHeight velocity-
dc.contributor.affiliatedAuthor황, 진순-
dc.contributor.affiliatedAuthor이, 해상-
dc.type.localJournal Papers-
dc.identifier.doi10.1159/000489262-
dc.citation.titleHormone research in pædiatrics-
dc.citation.volume90-
dc.citation.number1-
dc.citation.date2018-
dc.citation.startPage54-
dc.citation.endPage63-
dc.identifier.bibliographicCitationHormone research in pædiatrics, 90(1). : 54-63, 2018-
dc.identifier.eissn1663-2826-
dc.relation.journalidJ016632818-
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Pediatrics & Adolescent Medicine
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