Efficacy and Safety Study of Sr-hGH in Comparison With Daily hGH in ISS Patients
Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
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).