Unknown
PHASE3
INTERVENTIONAL
NCT03635580
Efficacy and Safety of rhGH (Jintropin®) in Pediatric Participants With ISS
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
Phase 1: To evaluate the safety and efficacy of 0.05mg/kg/d of rhGH (Jintropin®) in the treatment of children with idiopathic short stature (ISS) in 52 weeks. Phase 2: To evaluate the safety and efficacy of rhGH (Jintropin®) in the treatment of children with ISS in 2 years
Interventions
Name:
Negative control
Type:
OTHER
Description:
Untreated-control group
Primary Outcomes
Measure:
ΔHtSDSca (The change of height standard deviation score of chronological age before and after treatment)
TimeFrame:
Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
Description:
ΔHtSDSca was the difference of HtSDSca before and after treatment, and HtSDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age.
Trial Information
NCT ID
NCT03635580
Status
Unknown
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Last Updated
December 15, 2025