Establishing Dose of Sr-hGH in ISS Patients
Conditions
Brief 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).
Interventions
DRUGhuman growth hormone self-injection
Sponsors
LG Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in height velocity at Week 26, cm/year | Week 0-26 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in height velocity, cm/year | at Week 13 |
| Change from baseline in height, cm | at Week 13 and 26 |
| Change from baseline in IGF (Insulin-like growth factor)-I and IGF-I SDS (standard deviation score) | at Week 13 and 26 |
Countries
South Korea
Outcome results
None listed