Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with growth hormone deficiency, as well as to study the dosage of PEG Somatropin.

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

Conditions
-----------------
Growth Hormone Deficiency

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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; 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
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-somatropin<br>30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks. | Biological: PEG-somatropin<br>* 30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ht SDSca (Height Standard Deviation Score for Chronological Age) | 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 | 
| Change of yearly growth velocity from baseline to 26 weeks | Height velocity calculate by formula | Baseline, 26 weeks after initiating treatment | 
| 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 | 26 weeks after initiating treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ht SDSBA (Height Standard Deviation Score for Bone Age) |  | Baseline,26 weeks after initiating treatment | 
| IGF-1 SDS (IGF-1 Standard Deviation Score) |  | Baseline,26 weeks after initiating treatment | 
| IGFBP-3 SDS (IGFBP-3 Standard Deviation Score) |  | Baseline,26 weeks after initiating treatment | 
| Skeletal maturity | Skeletal maturity=(Bone Age at 26 weeks-Bone Age at baseline)/treatment duration | Baseline,26 weeks after initiating treatment |