Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency
- Conditions
- Growth Hormone Deficiency
- Interventions
- Biological: PEG-somatropin
- Registration Number
- NCT03249480
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 900
-
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.
- 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PEG-somatropin PEG-somatropin 30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Skeletal maturity Baseline,26 weeks after initiating treatment Skeletal maturity=(Bone Age at 26 weeks-Bone Age at baseline)/treatment duration
IGF-1 SDS (IGF-1 Standard Deviation Score) Baseline,26 weeks after initiating treatment Ht SDSBA (Height Standard Deviation Score for Bone Age) Baseline,26 weeks after initiating treatment IGFBP-3 SDS (IGFBP-3 Standard Deviation Score) Baseline,26 weeks after initiating treatment
Trial Locations
- Locations (28)
China-Japan Friendship Hospital
🇨🇳Beijing, China
Children's Hospital of Hebei Province
🇨🇳Shijiazhuang, Hebei, China
Children's Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Shenzhen Children's Hospital
🇨🇳Shenzhen, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
Wuxi Children's Hospital
🇨🇳Wuxi, Jiangsu, China
Xuzhou Children's Hpspital
🇨🇳Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Kunming Children's Hospital
🇨🇳Kunming, Yunnan, China
The First People's Hospital of Yunnan Province
🇨🇳Kunming, Yunnan, China
Anhui Provincial Children's Hospital
🇨🇳Hefei, Anhui, China
Fuzhou Children s Hospital
🇨🇳Fuzhou, Fujian, China
Sun Yat-Sen Memorial Hospital
🇨🇳Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiangzhuang, Hebei, China
The First Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Children's Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Henan Provincal People's Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Henan University of TCM
🇨🇳Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, HUST
🇨🇳Wuhan, Hubei, China
Wuhan Children's Hospital
🇨🇳Wuhan, Hubei, China
Hunan Children's Hospital
🇨🇳Changsha, Hunan, China
Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanjing, Jiangsu, China
Nanjing Children's Hospital
🇨🇳Nanjing, Jiangsu, China
Dalian Children's Hospital
🇨🇳Dalian, Liaoning, China
Xi'an Children's Hospital
🇨🇳Xi'an, Shanxi, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Second Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Peking University Third Hospital
🇨🇳Beijing, China