Clinical Research Directory

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

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.