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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.
DC Field | Value | Language |
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dc.contributor.author | 김호성 | - |
dc.date.accessioned | 2018-11-16T16:46:47Z | - |
dc.date.available | 2018-11-16T16:46:47Z | - |
dc.date.issued | 2018 | - |
dc.identifier.issn | 1663-2818 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/165316 | - |
dc.description.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. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | Karger | - |
dc.relation.isPartOf | HORMONE RESEARCH IN PAEDIATRICS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II Study. | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Pediatrics (소아청소년과학교실) | - |
dc.contributor.googleauthor | Jin Soon Hwang | - |
dc.contributor.googleauthor | Hae Sang Lee | - |
dc.contributor.googleauthor | Kee-Hyoung Lee | - |
dc.contributor.googleauthor | Han-Wook Yoo | - |
dc.contributor.googleauthor | Dae-Yeol Lee | - |
dc.contributor.googleauthor | Byung-Kyu Suh | - |
dc.contributor.googleauthor | Cheol Woo Ko | - |
dc.contributor.googleauthor | Woo Yeong Chung | - |
dc.contributor.googleauthor | Dong-Kyu Jin | - |
dc.contributor.googleauthor | Choong Ho Shin | - |
dc.contributor.googleauthor | Heon-Seok Han | - |
dc.contributor.googleauthor | Song Han | - |
dc.contributor.googleauthor | Ho-Seong Kim | - |
dc.identifier.doi | 10.1159/000489262 | - |
dc.contributor.localId | A01184 | - |
dc.relation.journalcode | J03514 | - |
dc.identifier.eissn | 1663-2826 | - |
dc.identifier.pmid | 29925064 | - |
dc.subject.keyword | Height velocity | - |
dc.subject.keyword | Idiopathic short stature | - |
dc.subject.keyword | Sustained-release growth hormone | - |
dc.contributor.alternativeName | Kim, Ho Seong | - |
dc.contributor.affiliatedAuthor | 김호성 | - |
dc.citation.volume | 90 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 54 | - |
dc.citation.endPage | 63 | - |
dc.identifier.bibliographicCitation | HORMONE RESEARCH IN PAEDIATRICS, Vol.90(1) : 54-63, 2018 | - |
dc.identifier.rimsid | 58730 | - |
dc.type.rims | ART | - |
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