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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

Title
Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency
Authors
Jin Soon Hwang;Hae Sang Lee;Sei Won Yang;Duk-Hee Kim;Yoon Ju Bae;Jin-Hwa Lee;Hyi-Jeong Ji;Han-Wook Yoo;Byung-Kyu Suh;Jeh-Hoon Shin;Kee-Hyoung Lee;Dae-Yeol Lee;Byung-Churl Lee;Cheol-Woo Ko;Ho-Seong Kim;Dong-Kyu Jin;Heon-Seok Han;Woo Yeong Chung
Issue Date
2013
Journal Title
European Journal of Endocrinology
ISSN
0804-4643
Citation
European Journal of Endocrinology, Vol.169(2) : 179~185, 2013
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 No subjects were withdrawn due to adverse events.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.
URI
http://eje-online.org/content/169/2/179.long

http://ir.ymlib.yonsei.ac.kr/handle/22282913/88438
DOI
10.1530/EJE-13-0148
Appears in Collections:
1. 연구논문 > 1. College of Medicine > Dept. of Pediatrics
Yonsei Authors
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