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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.

Authors
Hwang, JS; Lee, HS; Chung, WY; Han, HS; Jin, DK; Kim, HS; Ko, CW; Lee, BC; Lee, DY; Lee, KH; Shin, JH; Suh, BK; Yoo, HW; Ji, HJ; Lee, JH; Bae, YJ; Kim, DH; Yang, SW
Citation
European journal of endocrinology, 169(2):179-185, 2013
Journal Title
European journal of endocrinology
ISSN
0804-46431479-683X
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 No subjects were withdrawn due to adverse events.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.
MeSH terms
Body Height/*drug effectsChi-Square DistributionChildChild, PreschoolDelayed-Action PreparationsFemaleHuman Growth Hormone/*administration & dosage/*deficiencyHumansInjections, SubcutaneousInsulin-Like Growth Factor Binding Protein 3/bloodInsulin-Like Growth Factor I/analysisMaleRecombinant Proteins/administration & dosageRepublic of Korea
DOI
10.1530/EJE-13-0148
PMID
23682096
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Pediatrics & Adolescent Medicine
AJOU Authors
황, 진순이, 해상
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