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

Recruiting

• Conditions: Turner Syndrome; Growth Hormone Deficiency; Idiopathic Short Stature; Small for Gestational Age

• Registration Number: NCT04798690
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-08
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12
• Primary Completion: 2031-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 BMI SDS	Up to 2 years after epiphyseal closure	To assess the changes in BMI SDS between baseline and every 6 months
Changes in Height SDS	Up to 2 years after epiphyseal closure	To assess the changes in Height SDS 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
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
Changes in IGFBP-3	Up to 2 years after epiphyseal closure	To assess the changes in IGFBP-3 between baseline and every 6 months

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Seodaemun-gu, Korea, Republic of