Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.

Official Title
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Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial II

Conditions
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Growth Hormone Deficiency

Intervention / Treatment
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* Biological: PEG-somatropin
* Biological: PEG-somatropin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Before starting treatment, the child is diagnosed as GHD according to medical history,clinical symptoms and signs, GH provocation tests and imaging examinators and other examinators. According to the height statistical data of Chinese children's physical development in nine cities in 2015, the height of the child is lower than the third percentile of normal children's growth curve in the same age and same gender. Height velocity (HV) ≤5.0 cm/yr. GH provocation tests with two different mechanisms showed that GH peak concentration of the child is < 10.0ng/ml. Bone age (BA) ≤9 years in girls or ≤ 10 years in boys, and the BA is 1 year less than the CA. Prepuberty status (Tanner I stage), age ≥3 years old, girls and boys are acceptable. The child did not receive the treatment of growth hormone within 6 months. Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, and they sign informed consent. Exclusion Criteria: The child is dysfunction of liver and kidney (ALT) 2 times of the upper limit of normal value, Cr> the upper limit of normal value). The child has positive hepatitis B core antibody (HBc), hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg). The child is known as hypersensitivity to PEG Somatropin. The child has severe cardiopulmonary, hematological diseases, malignant tumors, general infection or immunodeficiency diseases. The child has potential tumor (family history). The child has diabetics. The child has abnormal growth and development, such as Turner's syndrome, constitutional delay of growth and puberty, Laron syndrome, growth hormone receptor deficiency, short stature girls with potential chromosomal abnormalities. The child took part in other clinical trials within 3 months. Other conditions are excluded when the investigator preclude the enrollment into the study.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 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: PEG-somatropin<br>Low dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks. | Biological: PEG-somatropin<br>* High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.<br>Biological: PEG-somatropin<br>* Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.<br>|
| Experimental: PEG-Somatropin<br>High dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks. | Biological: PEG-somatropin<br>* High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.<br>Biological: PEG-somatropin<br>* Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA) | HtSDSCA = (Height at the evaluated time point- the mean value of normal children in the same gender and same age) / the height SD of normal children in the same gender and same age | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HtSDSBA | HtSDSBA = (height at the evaluated time point-the mean value of normal children in the same gender and same age) / height SD of normal children in the same bone age and same gender | 26 weeks | 
| Annual height velocity | Annual Growth Velocity (cm/yr) = 12×(Height at the end of treatment-Height at the beginning of treatment)/the treatment duration (month) | 26 weeks | 
| Standard Deviation Score of serum IGF-1 (IGF-1 SDS) | IGF-1 SDS = (actual concentration of IGF-1-the median of IGF-1 concentration of normal children in the age and same gender) / SD of IGF-1 concentration of normal children in the same gender and same age | 26 weeks | 
| Bone Maturation | Bone Maturation = (BA at the end of treatment-BA at the beginning of treatment)/ the treatment duration (Year) | 26 weeks |