title: Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency.
abstract: OBJECTIVE
  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 No subjects were withdrawn due to adverse events.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pediatrics, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: Jin Soon
authors.initials: JS
authors.lastname: Hwang
authors.forename: Hae Sang
authors.initials: HS
authors.lastname: Lee
authors.forename: Woo Yeong
authors.initials: WY
authors.lastname: Chung
authors.forename: Heon-Seok
authors.initials: HS
authors.lastname: Han
authors.forename: Dong-Kyu
authors.initials: DK
authors.lastname: Jin
authors.forename: Ho-Seong
authors.initials: HS
authors.lastname: Kim
authors.forename: Cheol-Woo
authors.initials: CW
authors.lastname: Ko
authors.forename: Byung-Churl
authors.initials: BC
authors.lastname: Lee
authors.forename: Dae-Yeol
authors.initials: DY
authors.lastname: Lee
authors.forename: Kee-Hyoung
authors.initials: KH
authors.lastname: Lee
authors.forename: Jeh-Hoon
authors.initials: JH
authors.lastname: Shin
authors.forename: Byung-Kyu
authors.initials: BK
authors.lastname: Suh
authors.forename: Han-Wook
authors.initials: HW
authors.lastname: Yoo
authors.forename: Hyi-Jeong
authors.initials: HJ
authors.lastname: Ji
authors.forename: Jin-Hwa
authors.initials: JH
authors.lastname: Lee
authors.forename: Yoon Ju
authors.initials: YJ
authors.lastname: Bae
authors.forename: Duk-Hee
authors.initials: DH
authors.lastname: Kim
authors.forename: Sei Won
authors.initials: SW
authors.lastname: Yang
mesh_terms: D001827:Body Height / Q000187:drug effects*; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D003692:Delayed-Action Preparations; D005260:Female; D019382:Human Growth Hormone / Q000008:administration & dosage* / Q000172:deficiency*; D006801:Humans; D007279:Injections, Subcutaneous; D018972:Insulin-Like Growth Factor Binding Protein 3 / Q000097:blood; D007334:Insulin-Like Growth Factor I / Q000032:analysis; D008297:Male; D011994:Recombinant Proteins / Q000008:administration & dosage; D056910:Republic of Korea
chemical_list: D003692:Delayed-Action Preparations; C515497:IGFBP3 protein, human; D018972:Insulin-Like Growth Factor Binding Protein 3; D011994:Recombinant Proteins; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I