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Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency.

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dc.contributor.authorHwang, JS-
dc.contributor.authorLee, HS-
dc.contributor.authorChung, WY-
dc.contributor.authorHan, HS-
dc.contributor.authorJin, DK-
dc.contributor.authorKim, HS-
dc.contributor.authorKo, CW-
dc.contributor.authorLee, BC-
dc.contributor.authorLee, DY-
dc.contributor.authorLee, KH-
dc.contributor.authorShin, JH-
dc.contributor.authorSuh, BK-
dc.contributor.authorYoo, HW-
dc.contributor.authorJi, HJ-
dc.contributor.authorLee, JH-
dc.contributor.authorBae, YJ-
dc.contributor.authorKim, DH-
dc.contributor.authorYang, SW-
dc.date.accessioned2014-05-23T01:04:59Z-
dc.date.available2014-05-23T01:04:59Z-
dc.date.issued2013-
dc.identifier.issn0804-4643-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/10101-
dc.description.abstractPURPOSE: The purpose of this study was to investigate the efficacy and safety of LB03002, a sustained-release human GH (SR-hGH), compared with that of daily rhGH for 12 months in children with GH deficiency (GHD).



METHODS: A total of 73 children with GHD were screened and 63 eligible subjects were randomized in a 1:1 ratio of LB03002 (SR-hGH) to daily rhGH treatment group. LB03002 was administered once weekly at a dose of 0.5 mg/kg while daily rhGH was administered for 6 consecutive days with equally divided doses to make a total of 0.21 mg/kg per week. Treatments were given for 12 months by s.c. injections. Injection site reactions and adverse events were investigated throughout the study period.



RESULTS: The mean (S.D.) height velocity (HV) SHOWED a clinically significant increase after the 6-month treatment: 3.00 (1.15) cm/year at screening to 9.78 (1.98) cm/year at 6 months in the LB03002 group; 2.39 (1.63) cm/year at screening to 10.56 (2.65) cm/year at 6 months in the daily rhGH group. The increased HV at 12 months was still maintained in both the groups: 9.06 (1.63) cm/year at 12 months in the LB03002 group; 9.72 (2.32) cm/year at 12 months in the daily rhGH group. Most of the adverse drug reactions were mild and tolerable. No subjects were withdrawn due to adverse events.



CONCLUSION: Weekly injection of LB03002 at a dose of 0.5 mg/kg per week was confirmed to have comparable efficacy to daily injection of rhGH at a dose of 0.21 mg/kg per week. Both formulations were well tolerated.
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dc.language.isoen-
dc.subject.MESHBody Height-
dc.subject.MESHChi-Square Distribution-
dc.subject.MESHChild-
dc.subject.MESHChild, Preschool-
dc.subject.MESHDelayed-Action Preparations-
dc.subject.MESHFemale-
dc.subject.MESHHuman Growth Hormone-
dc.subject.MESHHumans-
dc.subject.MESHInjections, Subcutaneous-
dc.subject.MESHInsulin-Like Growth Factor Binding Protein 3-
dc.subject.MESHInsulin-Like Growth Factor I-
dc.subject.MESHMale-
dc.subject.MESHRecombinant Proteins-
dc.subject.MESHRepublic of Korea-
dc.titleEfficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency.-
dc.typeArticle-
dc.identifier.pmid23682096-
dc.identifier.urlhttp://eje-online.org/cgi/pmidlookup?view=long&pmid=23682096-
dc.contributor.affiliatedAuthor황, 진순-
dc.contributor.affiliatedAuthor이, 해상-
dc.type.localJournal Papers-
dc.identifier.doi10.1530/EJE-13-0148-
dc.citation.titleEuropean journal of endocrinology-
dc.citation.volume169-
dc.citation.number2-
dc.citation.date2013-
dc.citation.startPage179-
dc.citation.endPage185-
dc.identifier.bibliographicCitationEuropean journal of endocrinology, 169(2). : 179-185, 2013-
dc.identifier.eissn1479-683X-
dc.relation.journalidJ008044643-
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Pediatrics & Adolescent Medicine
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