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NCT07815626
Phase 3 Study to Evaluate the Efficacy and Safety of Human Growth Hormone Injection (Sinotropin AQ) for the Treatment of Children With Idiopathic Short Stature
Conditions: Idiopathic Short Stature (ISS)
Sex: All
Ages: 3 Years – 11 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 240
Sponsor: Zhongshan Sansure Hygene Biomedicine Co., Ltd.
Location: Anhui Provincial Children's Hospital Hefei Anhui
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 1\. Tanner stage I (prepubertal) at informed consent: males aged 3 to \
Source: ClinicalTrials.gov (NCT07815626). StuddyBuddy aggregates publicly available trial information.
