Unknown
PHASE3
INTERVENTIONAL
NCT03245333
A Study of Recombinant Human Growth Hormone Injection for Short Children With Small for Small for Gestational Age(SGA)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short SGA children, further to evaluate the efficacy and safety of the treatment of short SGA children.
Interventions
Name:
Recombinant Human Growth Hormone Injection
Type:
DRUG
Description:
Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.
Name:
Recombinant Human Growth Hormone Injection
Type:
DRUG
Description:
Stage 2: After completing phase 1, patients are administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd weeks to the final height.
Primary Outcomes
Measure:
Change of height standard deviation score for chronological age (△Ht SDSCA)
TimeFrame:
52 weeks
Description:
△Ht SDS= Ht SDSafter treatment - Ht SDSbaseline Ht SDSCA = (height - reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint )
Trial Information
NCT ID
NCT03245333
Status
Unknown
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Last Updated
December 15, 2025