A Sustained Release Human Growth Hormone (LB03002):Efficacy and Safety Following Six-month Treatment in Children with Growth Hormone Deficiency (GHD) / 대한소아내분비학회지

ABSTRACT

BACKGROUND: LB03002[somatropin(rDNA origin) for injectable suspension] is a sustained release formulation of human growth hormone to be administered by once-a-week subcutaneous injections. Less frequent administration could provide a considerable improvement on compliance and convenience. OBJECTIVE: To determine the efficacy and safety of a LB03002 administered in children with GHD once weekly for 6 months. DESIGN: Open-label, active-controlled, randomised, parallel group, phase II study. PATIENTS A total of forty-two naive or previously treated, pre-pubertal children with GHD, confirmed by two different GH provocation tests, were randomised and received either LB03002(0.3 or 0.5 mg/kg/week) or Eutropin(TM)(daily rhGH, 0.3 mg/ kg/week divided 6 times a week) for 6 months. RESULTS: The pre-treatment(HV0) and 6-month annualised height velocity(HV6) are shown(mean+/-SD) in the table below ----------------------------------------------------------------------- LB03002 LB03002 EutropinTM 0.3 mg/kg/week 0.5 mg/kg/week 0.3 mg/kg/week ----------------------------------------------------------------------- N 10 13 13 HV0 3.1+/-1.0 3.9+/-1.5 3.0+/-1.1 HV6 9.3+/-2.3 10.2+/-2.3 11.1+/-2.5 ----------------------------------------------------------------------- Mean IGF-I and IGFBP-3 levels were significantly elevated from baseline values in all the study groups. LB03002 at all dose groups was safe and well tolerated. No clinically relevant adverse events or abnormal laboratory parameters were observed and there were no remarkable differences between groups or changes over time within groups regarding parameters for glucose and lipid metabolism including fasting glucose and haemoglobin A1c. Injection site reactions were mostly mild to occasionally moderate and resolved within 2 to 3 days post-dose without intervention. CONCLUSIONS: Treatment with LB03002 by weekly administration of the doses tested in the study resulted in comparable safety and efficacy to daily rhGH in pre-pubertal children with GHD.