Efficacy and Safety Study of Sr-hGH in Comparison With Daily hGH in ISS Patients

Study Overview
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Brief Summary
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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).

Official Title
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A Phase II, Multi-center, Randomized, Comparative, Parallel, Open, Dose Finding Study to Assess the Efficacy and Safety After 26 Week-treatment of Eutropin Plus (SR-hGH) Compared to Eutropin Inj. in Pre-pubertal Children With Idiopathic Short Stature

Conditions
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Establishing Dose of Sr-hGH in ISS Patients

Intervention / Treatment
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* Drug: human growth hormone self-injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sr-hGH 0.5 mg/kg/wk<br>Patients inject Eutropin plus (Sr-hGH) 0.5 mg/kg/wk every week himself/herself. | Drug: human growth hormone self-injection<br> <br> |
| Experimental: Sr-hGH 0.7 mg/kg/wk<br>Patients inject Eutropin plus (Sr-hGH) 0.7 mg/kg/wk every week himself/herself. | Drug: human growth hormone self-injection<br> <br> |
| Active Comparator: Daily hGH 0.37 mg/kg/wk<br>Patients inject Eutropin (daily hGH) 0.37 mg/kg/wk everyday for the first 6days a week himself/herself. | Drug: human growth hormone self-injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in height velocity at Week 26, cm/year |  | Week 0-26 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | at Week 13 and 26 |