An Open, Multi-center, Prospective and Retrospective Observational Study to Evaluate the Long-term Safety and Effectiveness of Growth Hormone (Eutropin Inj. / Eutropin Plus Inj.) Treatment With GHD, TS, CRF, SGA, ISS and PWS in Children

LG Chem1 site in 1 country6,000 target enrollmentJanuary 2012

ConditionsGrowth Hormone Deficiency Turner Syndrome Chronic Renal Failure Small for Gestational Age Idiopathic Short Stature

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Growth Hormone Deficiency
Sponsor: LG Chem
Enrollment: 6000
Locations: 1
Primary Endpoint: Safety measure : adverse event
Status: Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

December 31, 2032

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

LG Chem

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Safety measure : adverse event

Time Frame: up to 2 years after epiphyseal closure

Secondary Outcomes

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)