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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sr-hGH 0.5 mg/kg/wk | Experimental | Patients inject Eutropin plus (Sr-hGH) 0.5 mg/kg/wk every week himself/herself. |
|
| Sr-hGH 0.7 mg/kg/wk | Experimental | Patients inject Eutropin plus (Sr-hGH) 0.7 mg/kg/wk every week himself/herself. |
|
| Daily hGH 0.37 mg/kg/wk | Active Comparator | Patients inject Eutropin (daily hGH) 0.37 mg/kg/wk everyday for the first 6days a week himself/herself. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human growth hormone self-injection | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in height velocity at Week 26, cm/year | Week 0-26 |
| Measure | Description | 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) |
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Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ho Sung Kim | Seoul | Seoul | South Korea |
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| at Week 13 and 26 |