Growth Hormone Deficiency
Conditions
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.
Interventions
BIOLOGICALPEG-somatropin
30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.
Sponsors
Hunan Children's Hospital
Beijing Children's Hospital
Tianjin Medical University General Hospital
Peking University Third Hospital
China-Japan Friendship Hospital
Dalian Children's Hospital
Xian Children's Hospital
Wuhan Children's Hospital
Fuzhou Children s Hospital
Anhui Provincial Children's Hospital
Shenzhen Children's Hospital
Children's Hospital of Hebei Province
Second Affiliated Hospital of Xi'an Jiaotong University
Zhengzhou Children's Hospital, China
Children's Hospital of Soochow University
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
First Affiliated Hospital of Kunming Medical University
Kunming Children's Hospital
The First People's Hospital of Yunnan
Xuzhou Children's Hopspital
Henan Provincial People's Hospital
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
First Affiliated Hospital of Harbin Medical University
The Second Hospital of Hebei Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Union Hospital of Tongji Medical College of HUST
Wuxi Women's & Children's Hospital
The Second Affiliated Hospital of Kunming Medical University
Nanjing Children's Hospital
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed as GHD before starting treatment, according to medical history, clinical symptoms and signs, GH provocation tests and imaging and other examinations: 1. 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; 2. Height velocity (HV) ≤5.0 cm / yr; 3. GH provocative tests (with two drugs of different mechanism of action) confirmed plasma GH peak \<10.0 ng / ml; 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ht SDSca (Height Standard Deviation Score for Chronological Age) | Baseline | 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 |
| Change of yearly growth velocity from baseline to 26 weeks | Baseline, 26 weeks after initiating treatment | Height velocity calculate by formula |
| Ht SDSca | 26 weeks after initiating treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal maturity | Baseline,26 weeks after initiating treatment | Skeletal maturity=(Bone Age at 26 weeks-Bone Age at baseline)/treatment duration |
| IGFBP-3 SDS (IGFBP-3 Standard Deviation Score) | Baseline,26 weeks after initiating treatment | — |
| 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 | — |
Countries
China
Contacts
Primary ContactXiaohua Feng
Outcome results
None listed