Phase 1: To evaluate the safety and efficacy of 0.05mg/kg/d of rhGH (Jintropin®) in the treatment of children with idiopathic short stature (ISS) in 52 weeks. Phase 2: To evaluate the safety and efficacy of rhGH (Jintropin®) in the treatment of children with ISS in 2 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
480
Untreated-control group
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGHenan Children's Hospital
Zhengzhou, Henan, China
RECRUITINGJiangsu Province Hospital
ΔHtSDSca (The change of height standard deviation score of chronological age before and after treatment)
ΔHtSDSca was the difference of HtSDSca before and after treatment, and HtSDSca 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.
Time frame: Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
ΔHT (Change of height)
Time frame: Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
△BA/CA (bone age change / chronological age)
Time frame: Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
Yearly growth velocity
Time frame: Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
ΔIGF-1 SDS (Change of insulin-like growth factor 1 standard deviation score)
Time frame: Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGChildren's Hospital of Shanxi
Taiyuan, Shanxi, China
RECRUITINGThe Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
RECRUITINGThe Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGChildren's Hospital of Fudan University
Shanghai, China
RECRUITINGChildren's Hospital of Shanghai
Shanghai, China
RECRUITING