Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency
- Conditions
- Growth Hormone Deficiency
- Interventions
- Biological: PEG-somatropin
- Registration Number
- NCT02908958
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Brief Summary
To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 900
- Before starting treatment, the child is diagnosed as GHD according to medical history,clinical symptoms and signs, GH provocation tests and imaging examinators and other examinators.
- According to the height statistical data of Chinese children's physical development in nine cities in 2015, the height of the child is lower than the third percentile of normal children's growth curve in the same age and same gender.
- Height velocity (HV) ≤5.0 cm/yr.
- GH provocation tests with two different mechanisms showed that GH peak concentration of the child is < 10.0ng/ml.
- Bone age (BA) ≤9 years in girls or ≤ 10 years in boys, and the BA is 1 year less than the CA.
- Prepuberty status (Tanner I stage), age ≥3 years old, girls and boys are acceptable.
- The child did not receive the treatment of growth hormone within 6 months.
- Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, and they sign informed consent.
- The child is dysfunction of liver and kidney (ALT) 2 times of the upper limit of normal value, Cr> the upper limit of normal value).
- The child has positive hepatitis B core antibody (HBc), hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg).
- The child is known as hypersensitivity to PEG Somatropin.
- The child has severe cardiopulmonary, hematological diseases, malignant tumors, general infection or immunodeficiency diseases.
- The child has potential tumor (family history).
- The child has diabetics.
- The child has abnormal growth and development, such as Turner's syndrome, constitutional delay of growth and puberty, Laron syndrome, growth hormone receptor deficiency, short stature girls with potential chromosomal abnormalities.
- The child took part in other clinical trials within 3 months.
- Other conditions are excluded when the investigator preclude the enrollment into the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEG-Somatropin PEG-somatropin High dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks. PEG-somatropin PEG-somatropin Low dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.
- Primary Outcome Measures
Name Time Method The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA) 26 weeks HtSDSCA = (Height at the evaluated time point- the mean value of normal children in the same gender and same age) / the height SD of normal children in the same gender and same age
- Secondary Outcome Measures
Name Time Method HtSDSBA 26 weeks HtSDSBA = (height at the evaluated time point-the mean value of normal children in the same gender and same age) / height SD of normal children in the same bone age and same gender
Bone Maturation 26 weeks Bone Maturation = (BA at the end of treatment-BA at the beginning of treatment)/ the treatment duration (Year)
Annual height velocity 26 weeks Annual Growth Velocity (cm/yr) = 12×(Height at the end of treatment-Height at the beginning of treatment)/the treatment duration (month)
Standard Deviation Score of serum IGF-1 (IGF-1 SDS) 26 weeks IGF-1 SDS = (actual concentration of IGF-1-the median of IGF-1 concentration of normal children in the age and same gender) / SD of IGF-1 concentration of normal children in the same gender and same age
Trial Locations
- Locations (22)
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Guangzhou Women and Children's Medical Center
🇨🇳Guangzhou, Guangdong, China
Qilu Children's Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Zhejiang Provincial Hospital of Traditional Chinese Medcine Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Ningbo Women and Children's Hospital
🇨🇳Ningbo, Zhejiang, China
Shaoxing Second Hospital
🇨🇳Shaoxing, Zhejiang, China
Southwest Hospital, Third Military Medical University
🇨🇳Chongqing, China
Shanghai Children's Medical Center
🇨🇳Shanghai, China
The Second Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Wuhu No.1 People's Hospital
🇨🇳Wuhu, Anhui, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
The Third Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Harbin Children's Hospital
🇨🇳Harbin, Heilongjiang, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Xiangya Hospital, Central South University
🇨🇳Changsha, Hunan, China
Children's Hospital of Changchun
🇨🇳Changchun, Jilin, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Chengdu Women and Children's Central Hospital
🇨🇳Chengdu, Sichuan, China
Hangzhou First People's Hospital
🇨🇳Hangzhou, Zhejiang, China
The Children's Hospital ,Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China