This study aims to explore the optimal dose of pegylated recombinant human growth hormone (PEG-rhGH) injection to treat children of Turner syndrome (TS), preliminarily evaluate its safety and efficacy and provide scientific and reliable evidence for the medication dosage in Phase 3 clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
PEG-rhGH Injection 0.1 mg/kg/w by subcutaneous injection for 52 weeks.
PEG-rhGH Injection 0.2 mg/kg/w by subcutaneous injection for 52 weeks.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGAffiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
RECRUITINGChange of height standard deviation score before and after treatment (ΔHT SDS)
The change of height standard deviation score of chronological age before and after treatment
Time frame: 52 weeks
Height Velocity
Annual growth rate at the end of treatment
Time frame: 52 weeks
ΔBA/ΔCA
Bone maturation (changes of bone age/ chang of chronological age)
Time frame: 52 weeks
IGF-1(Insulin-like growth factor 1) SDS
Time frame: 52 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGThe Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGBeijing Children's Hospital,Capital Medical University
Beijing, China
RECRUITINGChildren's Hospital of Fudan University
Shanghai, China
RECRUITINGShanghai Children's Hospital
Shanghai, China
RECRUITINGXinhua Hospital of Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITING