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NCT04798690 Clinical Trial

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

Growth Hormone Deficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04798690
Other study ID # DA3002_SS_OS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 8, 2021
Est. completion date December 2031

Study information
Verified date April 2023
Source Dong-A ST Co., Ltd.
Contact Sung
Phone +82-2-920-8369
Email jhsung@donga.co.kr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 2500
Est. completion date December 2031
Est. primary completion date December 2031
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Yonsei University Health System, Severance Hospital Seoul Seodaemun-gu

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long term safety assessed through the adverse events Number of occurrence of treatment-related adverse events Up to 2 years after epiphyseal closure
Secondary Change of annualized height velocity To assess the difference in change of annualized height velocity between baseline and every 6 months Up to 2 years after epiphyseal closure
Secondary The difference between target height and final height To assess the difference in target height and final height Up to 2 years after epiphyseal closure
Secondary Changes in Height SDS To assess the changes in Height SDS between baseline and every 6 months Up to 2 years after epiphyseal closure
Secondary Changes in skeletal maturity To assess the changes in skeletal maturity between baseline and every 6 months Up to 2 years after epiphyseal closure
Secondary Changes in IGF-1 To assess the changes in IGF-1 between baseline and every 6 months Up to 2 years after epiphyseal closure
Secondary Changes in IGFBP-3 To assess the changes in IGFBP-3 between baseline and every 6 months Up to 2 years after epiphyseal closure
Secondary Changes in BMI SDS To assess the changes in BMI SDS between baseline and every 6 months Up to 2 years after epiphyseal closure
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