A Randomized Controlled Phase 3 Study on the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Idiopathic Short Stature.

ABSTRACT:

Background

To evaluate the safety and efficacy of daily somatropin (Jintropin^®), a recombinant human growth hormone, in prepubertal children with ISS in China.

Methods

This study was a multicenter, randomized, controlled, open-label, phase 3 study. All subjects were randomized 3:1 to daily somatropin 0.05 mg/kg/day or no treatment for 52 weeks. A total of 481 subjects with a mean baseline age of 5.8 years were enrolled in the study. The primary endpoint was change in (△) height standard deviation score (HT-SDS) for chronological age (CA). Secondary endpoints included △height from baseline; △bone age (BA)/CA; △height velocity (HV) and △insulin-like growth factor 1 (IGF-1 SDS).

Results

△HT-SDS at week 52 was 1.04 ± 0.31 in the treatment group and 0.20 ± 0.33

SUBMITTER: Yuan J 

PROVIDER: S-EPMC9102803 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature