Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children

Study Overview
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Brief Summary
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To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of children with growth hormone deficiency for a relatively long period To explore the factors influencing the efficacy of PEG-Somatropin and to establish the height prediction model based on Chinese children with short stature, and to provide the basis and guidance for standard and reasonable long-term clinical application of PEG-Somatropin.

Official Title
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The Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children

Conditions
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Growth Retardation

Intervention / Treatment
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* Drug: PEG-somatropin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children has completed all visits and therapy in previous phase IV study; Investigators evaluate subjects could continue growth hormone therapy; 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: Children with epiphyseal closure; Children is near the adule final height, that is, growth rate≤ 2 cm / year or bone age ≥ 14 years old for girls, bone age ≥ 16 years old for boys; Dysfunction of liver and kidney (ALT> 2 times the upper limit of normal, Cr> upper limit of normal); 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; Patients with diabetics; Patients with congenital bone dysplasia or scoliosis; Patients took drugs that would influence the efficacy and safety of PEG-Somatropin after phase IV study and before screening for this extension study; Other conditions in which the investigator preclude enrollment into the study.

Ages Eligible for Study
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Minimum Age: 42 Months
Maximum Age: 15 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-somatropin-1<br>Dosage 0.2mg/kg/w | Drug: PEG-somatropin<br>* Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit<br>* Other names: Jintrolong®;|
| Experimental: PEG-somatropin-2<br>Dosage 0.1-0.2mg/kg/w | Drug: PEG-somatropin<br>* Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit<br>* Other names: Jintrolong®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ht SDSca (Height standard deviation score for chronological age) | 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, every 13 weeks until 130 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ht SDSBA (Height standard deviation score for bone age) |  | Baseline, every 13 weeks until 130 weeks | 
| Yearly growth velocity |  | Baseline, every 13 weeks until 130 weeks | 
| IGF-1 SDS (Standard deviation score of insulin-like growth factor-1) |  | Baseline, every 13 weeks until 130 weeks | 
| Bone age |  | Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks, 130 weeks | 
| Near final height for some subjects | When yearly growth velocity of some subject is no more than 2cm/year. | Baseline, every 13 weeks until 130 weeks |