rhGH (Jintropin®) 0.05mg/kg/d evaluated for efficacy and safety in pediatric idiopathic short stature over 52 weeks

Idiopathic short stature (ISS) is a condition where a child's height is significantly below average for their age and sex, without an identifiable medical cause. It can lead to psychosocial challenges and reduced quality of life. Current management often involves recombinant human growth hormone (rhGH) therapy, which aims to increase growth velocity and final adult height. However, long-term efficacy and safety profiles, especially with specific formulations like Jintropin®, require continuous evaluation to optimize treatment protocols and patient outcomes.

This Phase 1/2 clinical trial evaluates rhGH (Jintropin®) at 0.05mg/kg/d in pediatric participants diagnosed with idiopathic short stature (ISS). The study is designed to assess both the safety and efficacy of this specific dose. Phase 1 will track outcomes over 52 weeks, while Phase 2 extends the observation period to 2 years. The primary endpoints focus on growth parameters and adverse event reporting in this population.

As this record describes an ongoing or planned clinical trial, specific efficacy and safety findings are not yet available. The study aims to generate data on growth velocity, changes in height standard deviation score (SDS), and the incidence of adverse events over 52 weeks and 2 years of treatment with rhGH (Jintropin®). Future results are expected to quantify the impact of 0.05mg/kg/d dosing on growth outcomes and provide a detailed safety profile for pediatric patients with idiopathic short stature. This research will contribute to understanding the long-term effects of growth hormone therapy in this specific population.

The trial's primary objective is to evaluate the safety and efficacy of 0.05mg/kg/d rhGH (Jintropin®) in children with ISS over 52 weeks and 2 years.