Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature

Open, Multi-center, Non-interventional, Prospective/ Retrospective Observational Study on Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04798690

Enrollment

5000

Registered

2021-03-15

Start date

2021-02-08

Completion date

2035-02-01

Last updated

2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency, Idiopathic Short Stature, Small for Gestational Age, Turner Syndrome

Brief summary

This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

Inclusion criteria

* Children with short stature by growth hormone deficiency(GHD) or idiopathic short stature (ISS) or turner's syndrome(TS) or small for gestational age(SGA) * Children who has official height record at least 6 months prior

Exclusion criteria

* Children with Epiphyseal closure

Design outcomes

Primary

Measure	Time frame	Description
Long term safety assessed through the adverse events	Up to 2 years after epiphyseal closure	Number of occurrence of treatment-related adverse events

Secondary

Measure	Time frame	Description
Change of annualized height velocity	Up to 2 years after epiphyseal closure	To assess the difference in change of annualized height velocity between baseline and every 6 months
The difference between target height and final height	Up to 2 years after epiphyseal closure	To assess the difference in target height and final height
Changes in Height SDS	Up to 2 years after epiphyseal closure	To assess the changes in Height SDS between baseline and every 6 months
Changes in skeletal maturity	Up to 2 years after epiphyseal closure	To assess the changes in skeletal maturity between baseline and every 6 months
Changes in IGF-1	Up to 2 years after epiphyseal closure	To assess the changes in IGF-1 between baseline and every 6 months
Changes in IGFBP-3	Up to 2 years after epiphyseal closure	To assess the changes in IGFBP-3 between baseline and every 6 months
Changes in BMI SDS	Up to 2 years after epiphyseal closure	To assess the changes in BMI SDS between baseline and every 6 months

Countries

South Korea

Contacts

CONTACTSung

jhsung@donga.co.kr+82-2-920-8369

Outcome results