Efficacy and Safety Study of Sr-hGH in Comparison With Daily hGH in ISS Patients
Efficacy and Safety Study of Sr-hGH in Comparison With Daily hGH in ISS Patients
The purpose of this study is to assess dosing requirements and establish the efficacy of
 SR-hGH in idiopathic short stature patients (ISS). This phase II study is designed as
 multi-center, randomized, active comparator-controlled, parallel, open-label.

 45 patients were randomized to three arms with 1:1:1 ratio, two arms of Sr-hGH and one of
 daily hGH. Two doses of Sr-hGH were administered, which are 0.5 and 0.7mg/kg/week. And the
 other arm received daily hGH at 0.37 mg/kg/week.

 Patients in Sr-hGH groups injected on a specific day of the every week for 26 weeks. And
 patients randomized to daily hGH group injected for 6 days a week.

 Patients visited study centers five times, firstly at screening (Visit 1), at randomization
 (Visit 2), after 13th dosing (Visit 3), after 26th dosing (Visit 4), and finally for
 follow-up (Visit5).
Criteria

 -  are older than or equal to age of 4

 -  are pre-pubertal (Tanner's stage I)

 -  are younger than bone age of 9 in female; of 11 in male

 -  have less than 3 years of a difference in bone and chronological age

 -  have confirmed idiopathic short stature