Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)
- Conditions
- Growth Hormone Deficiency
- Interventions
- Biological: PEG-somatropin
- Registration Number
- NCT02380235
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Brief Summary
This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad of population of children.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
-
Before starting treatment, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.
- According to the height statistical data of Chinese children's physique development in nine cities in 2005,height is lower than the third percentile of growth curve of normal children with the same age and gender.
- Height velocity (HV) ≤5.0 cm/yr.
- GH stimulation test with two different mechanisms affirms that GH peak concentration of patients' plasma<10.0ng/ml.
- Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than his/her chronological age (CA).
-
Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.
-
Receive no prior GH treatment within 6 months.
-
Sign informed consent.
- People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal value, Cr> the upper limit of normal value).
- Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis Be antigen (HBeAg).
- People with known highly allergic constitution or allergy to the drug of the study.
- People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency.
- Diabetic.
- Potential tumor patients (family history).
- Abnormal growth and development, such as Turner syndrome, constitutional delay of growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome.
- Subjects took part in other clinical trial study within 3 months.
- Other conditions which in the opinion of the investigator preclude enrollment into the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEG-somatropin PEG-somatropin 0.12mg/kg/w PEG-Somatropin PEG-somatropin 0.20mg/kg/w
- 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
Trial Locations
- Locations (12)
Children's Hospital Affiliated to Capital Institute of Pediatrics
🇨🇳Beijing, Beijing, China
Chinese Academy of Medical Sciences &Peking Union Medical College
🇨🇳Beijing, Beijing, China
Children's Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Affiliated Hospital, Jiangnan University
🇨🇳Wuxi, Jiangsu, China
First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
West China Second University Hospital
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
Children's Hospital of Shanghai
🇨🇳Shanghai, Shanghai, China