Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency
- Conditions
- Growth Hormone Deficiency
- Interventions
- Biological: PEG-somatropin
- Registration Number
- NCT02976675
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Jintropin AQ PEG-somatropin Jintropin AQ, injection, 30IU/10 mg/3ml/cartridge, 0.25mg/kg/w, once per day for 26 weeks PEG-somatropin per two weeks PEG-somatropin 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 PEG-somatropin PEG-somatropin 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
- Primary Outcome Measures
Name Time Method Ht SDSca Baseline, 4,12,26 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 Outcome Measures
Name Time Method IGF-1/IGFBP-3 molar ratio Baseline, 4,12,26 weeks after initiating treatment Calculate by formula
Bone age Baseline, 4,12,26 weeks after initiating treatment Calculate by formula
Ht SDSBA Baseline, 4,12,26 weeks after initiating treatment Calculate by formula
Yearly growth velocity Baseline, 4,12,26 weeks after initiating treatment Calculate by formula
IGF-1SDS Baseline, 4,12,26 weeks after initiating treatment Calculate by formula
Trial Locations
- Locations (24)
Maternal and Child Health Hospital of Guiyang City
🇨🇳Guiyangtou, Guizhou, China
Hebei Provincial People's Hospital
🇨🇳Shijiazhuang, Hebei, China
Maternal and Child Health Hospital of Anhui province
🇨🇳Hefei, Anhui, China
First People's Hospital of Lu'an City
🇨🇳Lu'an, Anhui, China
Second Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Maternal and Child Health Hospital of Hainan province
🇨🇳Haikou, Hainan, China
First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Zhengzhou, Henan, China
Maternal and Child Health Hospital of Hubei province
🇨🇳Wuhan, Hubei, China
First People's Hospital of Changzhou City
🇨🇳Changzhou, Jiangsu, China
First People's Hospital of Lianyungang City
🇨🇳Lianyungang, Jiangsu, China
Jiangsu Provincial Hospital of Chinese Traditional medicine
🇨🇳Nanjingkou, Jiangsu, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
Suzhou City Hospital
🇨🇳Suzhou, Jiangsu, China
Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Maternal and Child Health Hospital of Tai'an city
🇨🇳Tai'an, Shandong, China
Children's Hospital of Chengdu city
🇨🇳Chengdu, Sichuan, China
People's Hospital of Cixi City
🇨🇳Cixi, Zhejiang, China
First People's Hospital of Jiaxing City
🇨🇳Jiaxing, Zhejiang, China
First People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Jinhua Central Hospital
🇨🇳Jinhua, Zhejiang, China
Peoples' hospital of Inner Mongolia Autonomous Region
🇨🇳Inner Mongolia Autonomous Region, China
General Hospital of Ningxia Medical University
🇨🇳Ningxia Autonomous Region, China
Children's Hospital of Fudan University
🇨🇳Shanghai, China
Jishuitan Hospital of Beijing City
🇨🇳Beijing, China