This study is a multicenter, randomized, open-label, active-controlled, non-inferiority Phase III clinical trial. It aims to evaluate the efficacy and safety of Human Growth Hormone (hGH) Injection (Sinotropin AQ) in pediatric participants with Idiopathic Short Stature (ISS). Eligible participants will be randomized to receive either the study drug or an active comparator for 52 weeks. The primary efficacy endpoint is height velocity (HV, cm/year) over the treatment period. The study drug will be administered subcutaneously once daily at a dose of 0.15 IU/kg. The results of this trial will provide evidence on whether hGH Injection represents an effective and safe treatment option for improving height in children with ISS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
This product is human growth hormone (hGH) injection (Sinotropin AQ). Usage and dosage: 0.15 IU/kg/day (0.05 mg/kg/day), once daily, administered by subcutaneous injection.
This product is human growth hormone (hGH) injection. Usage and dosage: 0.15 IU/kg/day (0.05 mg/kg/day), once daily, administered by subcutaneous injection
Anhui Provincial Children's Hospital
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Capital Center for Children's Health, Captical Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Guangdong Hospital for Materal and Child Health Care
Guangzhou, Guangdong, China
The value of Annual Height velocity
The value of Annual Height velocity (HV, cm/year)
Time frame: At the end of 52 weeks of treatment
The change of ΔHT SDS value
The change from baseline in height SDS (ΔHT SDS)
Time frame: At all visit points from baseline to week 52
The change of IGF-1 SDS value
The change of insulin-like growth factor-1 standard deviation score value
Time frame: At all visit points from baseline to Week 52
The change of height velocity value (ΔHV)
The change from baseline in height velocity(ΔHV)
Time frame: At all visit points from baseline to Week 52
The change of bone age relative to change of chronological age(ΔBA/ΔCA) value
The change of bone age (BA) relative to the change in chronological age (CA) from basline to end of 52-week treatment
Time frame: At all visit points from basline to week 52
The safety of human growth hormone injection
Evaluate all TEAEs, SAEs, and clinically significant abnormalities in laboratory tests, vital signs, and physical examination.
Time frame: Baseline, Week 13, Week 26, Week 39, and Week 52
Immunogenicity of Human Growth Hormone Injection
Assessment of anti-GH and neutralizing antibody incidence
Time frame: At all visit points from baseline to week 52
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Tangshan Maternal and Child Health Hospital
Tangshan, Hebei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Wuhan Children's Hospital
Wuhan, Hubei, China
...and 24 more locations