Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With 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 in the treatment of children with growth hormone deficiency, as well as to study the feasibility of extending the dosing intervals (once per two weeks) of PEG Somatropin Injection.

Official Title
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Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG Somatropin

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: Subjects are diagnosed as GHD before starting treatment, according to medical history, clinical symptoms and signs, GH provocation tests and imaging and other examinations: According to statistical height data of physical development of Chinese children in nine cities in 2005, the height is lower than 3rd percentile growth curve of the same age, same sex normal children; Height velocity (HV) ≤5.0 cm / yr; GH provocative tests (with two drugs of different mechanism of action) confirmed plasma GH peak <10.0 ng / ml; bone age for girl≤9 years old, for Boy≤10 years old, bone age is one year or more later than the actual age, that is the actual age - bone age ≥ 1 year; Before puberty (Tanner I stage), age≥3 years old, male or female; Subjects have not received hormone therapy within 6 months; Subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent. Exclusion Criteria: Dysfunction of liver and kidney (ALT> 2 times the upper limit of normal, Cr> upper limit of normal); Patients positive for hepatitis B c-antibody (HBcAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg); Patients with known hypersensitivity to PEG Somatropin or Somatropin or any other components of the study product; Patients with severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases; Potential cancer patients (family history); Patients with diabetics; Patients with other growth disorders, such as Turner's syndrome, sexual physical delayed puberty, Laron syndrome, growth hormone receptor deficiency, girls with slowly growing who did not rule out chromosomal abnormalities; Patients with congenital bone dysplasia or scoliosis; Subjects took part in other clinical trial study during 3 months; Other conditions in which the investigator preclude 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>Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks | Biological: PEG-somatropin<br>* Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks<br>Biological: PEG-somatropin<br>* Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks<br>|
| Experimental: PEG-somatropin per two weeks<br>Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks | Biological: PEG-somatropin<br>* Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks<br>Biological: PEG-somatropin<br>* Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks<br>|
| Active Comparator: Jintropin AQ<br>Jintropin AQ, injection, 30IU/10 mg/3ml/cartridge, 0.25mg/kg/w, once per day for 26 weeks | Biological: PEG-somatropin<br>* Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks<br>Biological: PEG-somatropin<br>* Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ht SDSca | Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age | Baseline, 4,12,26 weeks after initiating treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ht SDSBA | Calculate by formula | Baseline, 4,12,26 weeks after initiating treatment | 
| Yearly growth velocity | Calculate by formula | Baseline, 4,12,26 weeks after initiating treatment | 
| IGF-1SDS | Calculate by formula | Baseline, 4,12,26 weeks after initiating treatment | 
| IGF-1/IGFBP-3 molar ratio | Calculate by formula | Baseline, 4,12,26 weeks after initiating treatment | 
| Bone age | Calculate by formula | Baseline, 4,12,26 weeks after initiating treatment |