Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children

Recruiting

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

• Registration Number: NCT01604395
• Lead Sponsor: LG Chem

Brief Summary

The purpose of this study is to evaluate the long-term safety and effectiveness of growth hormone (Eutropin Inj./Eutropin plus Inj.) treatment with GHD (Growth Hormone Deficiency), TS (Turner Syndrome),CRF (Chronic Renal Failure), SGA (Small for Gestational Age), and ISS (Idiopathic Short Stature).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-23
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21
• Primary Completion: 2032-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

• short stature children aged 2 years or more
• children with GHD,TS, CRF, SGA or ISS
• written informed consent from the person, person's parent or legal guardian

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety measure : adverse event	up to 2 years after epiphyseal closure

Secondary Outcome Measures

Name	Time	Method
effectiveness : difference in height velocity between Baseline and every year	up to 2 years after epiphyseal closure
effectiveness measure : difference in target height and final height	up to 2 years after epiphyseal closure
effectiveness measure : difference in height SDS for CA between baseline and every 6 months	up to 2 years after epiphyseal closure

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of