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

N/ARecruitingNCT04798690

Dong-A ST Co., Ltd.2,500 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

2,500

Conditions

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

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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

Locations (1)

Yonsei University Health System, Severance Hospital

Seoul, Seodaemun-gu, South Korea

RECRUITING

Outcomes

Primary Outcomes

Long term safety assessed through the adverse events

Number of occurrence of treatment-related adverse events

Time frame: Up to 2 years after epiphyseal closure

Secondary Outcomes

Change of annualized height velocity

To assess the difference in change of annualized height velocity between baseline and every 6 months

Time frame: Up to 2 years after epiphyseal closure

The difference between target height and final height

To assess the difference in target height and final height

Time frame: Up to 2 years after epiphyseal closure

Changes in Height SDS

To assess the changes in Height SDS between baseline and every 6 months

Time frame: Up to 2 years after epiphyseal closure

Changes in skeletal maturity

To assess the changes in skeletal maturity between baseline and every 6 months

Time frame: Up to 2 years after epiphyseal closure

Changes in IGF-1

To assess the changes in IGF-1 between baseline and every 6 months

Time frame: Up to 2 years after epiphyseal closure

Changes in IGFBP-3

To assess the changes in IGFBP-3 between baseline and every 6 months

Time frame: Up to 2 years after epiphyseal closure

Changes in BMI SDS

To assess the changes in BMI SDS between baseline and every 6 months

Central Contacts

Sung

CONTACT

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

Data from ClinicalTrials.gov

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