Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency
DC Field | Value | Language |
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dc.contributor.author | Hwang, Jin Soon | - |
dc.contributor.author | Lee, Hae Sang | - |
dc.contributor.author | Chung, Woo Yeong | - |
dc.contributor.author | Han, Heon-Seok | - |
dc.contributor.author | Jin, Dong-Kyu | - |
dc.contributor.author | Kim, Ho-Seong | - |
dc.contributor.author | Ko, Cheol-Woo | - |
dc.contributor.author | Lee, Byung-Churl | - |
dc.contributor.author | Lee, Dae-Yeol | - |
dc.contributor.author | Lee, Kee-Hyoung | - |
dc.contributor.author | Shin, Jeh-Hoon | - |
dc.contributor.author | Suh, Byung-Kyu | - |
dc.contributor.author | Yoo, Han-Wook | - |
dc.contributor.author | Ji, Hyi-Jeong | - |
dc.contributor.author | Lee, Jin-Hwa | - |
dc.contributor.author | Bae, Yoon Ju | - |
dc.contributor.author | Kim, Duk-Hee | - |
dc.contributor.author | Yang, Sei Won | - |
dc.date.accessioned | 2021-09-05T23:08:37Z | - |
dc.date.available | 2021-09-05T23:08:37Z | - |
dc.date.created | 2021-06-14 | - |
dc.date.issued | 2013-08 | - |
dc.identifier.issn | 0804-4643 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/102531 | - |
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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | BIOSCIENTIFICA LTD | - |
dc.subject | GROWTH-HORMONE DEFICIENCY | - |
dc.subject | DOUBLE-BLIND | - |
dc.subject | ADHERENCE | - |
dc.title | Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Lee, Kee-Hyoung | - |
dc.identifier.doi | 10.1530/EJE-13-0148 | - |
dc.identifier.scopusid | 2-s2.0-84880963805 | - |
dc.identifier.wosid | 000322518200008 | - |
dc.identifier.bibliographicCitation | EUROPEAN JOURNAL OF ENDOCRINOLOGY, v.169, no.2, pp.179 - 185 | - |
dc.relation.isPartOf | EUROPEAN JOURNAL OF ENDOCRINOLOGY | - |
dc.citation.title | EUROPEAN JOURNAL OF ENDOCRINOLOGY | - |
dc.citation.volume | 169 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 179 | - |
dc.citation.endPage | 185 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Endocrinology & Metabolism | - |
dc.relation.journalWebOfScienceCategory | Endocrinology & Metabolism | - |
dc.subject.keywordPlus | GROWTH-HORMONE DEFICIENCY | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | ADHERENCE | - |
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