Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 신재훈 | - |
dc.date.accessioned | 2018-03-09T04:46:11Z | - |
dc.date.available | 2018-03-09T04:46:11Z | - |
dc.date.issued | 2013-03 | - |
dc.identifier.citation | EUROPEAN JOURNAL OF ENDOCRINOLOGY; AUG 2013, 169, 2, p179-p185, 7p. | en_US |
dc.identifier.issn | 0804-4643 | - |
dc.identifier.uri | http://www.eje-online.org/content/169/2/179.full | - |
dc.identifier.uri | http://hdl.handle.net/20.500.11754/44102 | - |
dc.description.abstract | Purpose: 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 No subjects were withdrawn due to adverse events.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. | en_US |
dc.description.sponsorship | Financial support for this study was provided by LG Life Sciences, Ltd., Republic of Korea. H-J Ji, J-H Lee, and Y J Bae are employed by LG Life Sciences. J S Hwang, W Y Chung, D-K Jin, C-W Ko, H-W Yoo, D-H Kim, and S W Yang received consulting fees from LG Life Sciences, Ltd., Republic of Korea. | en_US |
dc.language.iso | en | en_US |
dc.publisher | BIOSCIENTIFICA LTD | en_US |
dc.subject | GROWTH-HORMONE DEFICIENCY | en_US |
dc.subject | DOUBLE-BLIND | en_US |
dc.subject | ADHERENCE | en_US |
dc.title | Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency | en_US |
dc.type | Article | en_US |
dc.relation.volume | 169 | - |
dc.identifier.doi | 10.1530/EJE-13-0148 | - |
dc.relation.page | 179-185 | - |
dc.relation.journal | EUROPEAN JOURNAL OF ENDOCRINOLOGY | - |
dc.contributor.googleauthor | Hwang, Jin Soon | - |
dc.contributor.googleauthor | Lee, Hae Sang | - |
dc.contributor.googleauthor | Chung, Woo Yeong | - |
dc.contributor.googleauthor | Han, Heon-Seok | - |
dc.contributor.googleauthor | Jin, Dong-Kyu | - |
dc.contributor.googleauthor | Kim, Ho-Seong | - |
dc.contributor.googleauthor | Ko, Cheol-Woo | - |
dc.contributor.googleauthor | Lee, Byung-Churl | - |
dc.contributor.googleauthor | Lee, Dae-Yeol | - |
dc.contributor.googleauthor | Shin, Jeh-Hoon | - |
dc.relation.code | 2013009848 | - |
dc.sector.campus | S | - |
dc.sector.daehak | COLLEGE OF MEDICINE[S] | - |
dc.sector.department | DEPARTMENT OF MEDICINE | - |
dc.identifier.pid | hjshin | - |
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