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Efficacy and safety of the recombinant human growth hormone in short children born small for gestational age: A randomized, multicentre, comparative phase III trial
DC Field | Value | Language |
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dc.contributor.author | 김호성 | - |
dc.date.accessioned | 2021-12-28T17:18:07Z | - |
dc.date.available | 2021-12-28T17:18:07Z | - |
dc.date.issued | 2021-07 | - |
dc.identifier.issn | 0025-7974 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/187034 | - |
dc.description.abstract | Objective: Growth hormone (GH) treatment is known to be effective in increasing stature in children with a short stature born small for gestational age (SGA). This multicentre, randomized, open-label, comparative, phase III study aimed to evaluate the efficacy and safety of Growtropin-II (recombinant human GH) and to demonstrate that the growth-promoting effect of Growtropin-II is not inferior to that of Genotropin in children with SGA (NCT ID: NCT02770157). Methods: Seventy five children who met the inclusion criteria were randomized into 3 groups in a ratio of 2:2:1 (the study group [Growtropin-II, n = 30], control group [Genotropin, n = 30], and 26-week non-treatment group [n = 15]). The study and control groups received subcutaneous injections of Growtropin-II and Genotropin, respectively for 52 weeks, whereas the non-treatment group underwent a non-treatment observation period during weeks 0 to 26 and a dosing period during weeks 27 to 52 and additional dosing till week 78 only in re-consenting children. Results: No significant differences in demographic and baseline characteristics between the groups were observed. The mean ± standard deviation change difference in annualized height velocity (aHV) (study group - control group) was 0.65 ±2.12 cm/year (95% confidence interval [CI], -0.53 to 1.83), whereas the lower limit for the 2-sided 95% CI was -0.53 cm/year. Regarding safety, treatment-emergent adverse events (TEAEs) occurred in 53.33% children in the study group and 43.33% children in the control group; the difference in the incidence of TEAEs between the 2 treatment groups was not statistically significant (P = .4383). A total of 17 serious adverse events (SAEs) occurred in 13.33% children in the treatment groups, and no significant difference in incidence between groups (P = .7065) was seen. Two cases of adverse drug reaction (ADR) occurred in 2 children (3.33%): 1 ADR (injection site swelling or pain) occurred in 1 child (3.33%) each in the study and control groups. Conclusions: This study demonstrates that the change in aHV from the baseline till 52 weeks with Growtropin-II treatment is non-inferior to that with Genotropin treatment in children with short stature born SGA. Growtropin-II is well-tolerated, and its safety profile is comparable with that of Genotropin over a 1-year course of treatment. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Lippincott Williams & Wilkins | - |
dc.relation.isPartOf | MEDICINE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Child | - |
dc.subject.MESH | Child, Preschool | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Human Growth Hormone / therapeutic use* | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Infant, Newborn | - |
dc.subject.MESH | Infant, Small for Gestational Age | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Recombinant Proteins / therapeutic use* | - |
dc.title | Efficacy and safety of the recombinant human growth hormone in short children born small for gestational age: A randomized, multicentre, comparative phase III trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Pediatrics (소아과학교실) | - |
dc.contributor.googleauthor | Su Jin Kim | - |
dc.contributor.googleauthor | Min-Sun Kim | - |
dc.contributor.googleauthor | Sung Yoon Cho | - |
dc.contributor.googleauthor | Byung-Kyu Suh | - |
dc.contributor.googleauthor | Cheol Woo Ko | - |
dc.contributor.googleauthor | Kee-Hyoung Lee | - |
dc.contributor.googleauthor | Han-Wook Yoo | - |
dc.contributor.googleauthor | Choong Ho Shin | - |
dc.contributor.googleauthor | Jin Soon Hwang | - |
dc.contributor.googleauthor | Ho-Seong Kim | - |
dc.contributor.googleauthor | Woo Yeong Chung | - |
dc.contributor.googleauthor | Chan Jong Kim | - |
dc.contributor.googleauthor | Heon-Seok Han | - |
dc.contributor.googleauthor | Dong-Kyu Jin | - |
dc.identifier.doi | 10.1097/MD.0000000000026711 | - |
dc.contributor.localId | A01184 | - |
dc.relation.journalcode | J02214 | - |
dc.identifier.eissn | 1536-5964 | - |
dc.identifier.pmid | 34397702 | - |
dc.contributor.alternativeName | Kim, Ho Seong | - |
dc.contributor.affiliatedAuthor | 김호성 | - |
dc.citation.volume | 100 | - |
dc.citation.number | 30 | - |
dc.citation.startPage | e26711 | - |
dc.identifier.bibliographicCitation | MEDICINE, Vol.100(30) : e26711, 2021-07 | - |
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