A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA

Study Overview
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Brief Summary
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To preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose.

Official Title
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Phase Ⅱ Clinical Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for Gestational Age(SGA)

Conditions
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Small for Gestational Age Infant

Intervention / Treatment
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* Biological: Somatropin Injection low dose group
* Biological: Somatropin Injection high dose group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of small for gestational age, SGA. Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders. Prepubertal stage (Tanner I). Without catch-up growth in two years after birth. Height was lower than the mean -2SD of the values of normal children of the same age and gender when participating in the study. A GH peak concentration >10µg/L in a provocative test within a year before participate in the study. Bone age<Chronological age+1. Normal glucose regulation：Fasting blood-glucose < 5.6mmol/L and 2-hour postprandial blood glucose< 7.8mmol/L. Gestational age≥Gestational age≥ 36weeks + 4days. Never accepted growth hormone treatment. The subjects and their guardians signed informed consent. Exclusion Criteria: Subjects with Liver and renal insufficiency (ALT > 2 times of upper limit of normal value, Cr> upper limit of normal value). Patients with positive for antibodies to hepatitis B core (anti-HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)。 Known highly allergic constitution or allergic to the test drug. Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and hematological diseases, malignant tumors, or systemic infection, immunocompromised patients and patients with psychosis. Subjects with other types of abnormal growth and development, such as Turner syndrome, constitutional delay of puberty, Laron syndrome, growth hormone receptor deficiency. Subjects who have received the treatment of Somatropin or took part in other clinical trial study within 3 months. Other conditions which in the opinion of the investigator preclude enrollment into the study.

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 90 Months

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Somatropin Injection low dose group<br>0.23mg/kg /wk，inject for seven divided doses. | Biological: Somatropin Injection low dose group<br>* 0.23mg/kg /wk，inject for seven divided doses<br>Biological: Somatropin Injection high dose group<br>* 0.46mg/kg /wk，inject for seven divided dose<br>|
| Experimental: Somatropin Injection high dose group<br>0.46mg/kg /wk，inject for seven divided doses. | Biological: Somatropin Injection low dose group<br>* 0.23mg/kg /wk，inject for seven divided doses<br>Biological: Somatropin Injection high dose group<br>* 0.46mg/kg /wk，inject for seven divided dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height standard deviation score for chronological age (Ht SDSCA) | HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint) | 26 weeks | 
| Height standard deviation score for chronological age (Ht SDSCA) | HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint) | 52 weeks | 
| Height standard deviation score for chronological age (Ht SDSCA) | HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint) | 78 weeks | 
| Height standard deviation score for chronological age (Ht SDSCA) | HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint) | 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ΔHtSDSCA | Change in height SDS for chronological age (Ht SDSCA) | 26 weeks， 52 weeks，78 weeks and 104 weeks | 
| Change in HV | Change in annualized height velocity (HV) | 26 weeks， 52 weeks，78 weeks and 104 weeks | 
| Change in bone age maturation |  | 26 weeks， 52 weeks，78 weeks and 104 weeks | 
| Change in mole ratio of IGF-1 and IGFBP-3 |  | 26 weeks， 52 weeks，78 weeks and 104 weeks | 
| Change in PAH | Change in prediction of adult height (PAH) | 26 weeks， 52 weeks，78 weeks and 104 weeks | 
| Change in obesity prevalence |  | 26 weeks， 52 weeks，78 weeks and 104 weeks | 
| Change in overweight |  | 26 weeks， 52 weeks，78 weeks and 104 weeks |