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

Chronic Renal Failure Clinical Trial

— LGS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01604395
• Other study ID #: LG-HGOS001
• Status: Recruiting
• Start date: January 2012
• Est. completion date: December 31, 2032

Study information

• Verified date: February 2021
• Source: LG Chem
• Contact: YoungHwan Jang
• Phone: 82-2-6924-3158
• Email: younghj[@]lgls.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Dwarfism
• Gonadal Dysgenesis
• Growth Hormone Deficiency
• Idiopathic Short Stature
• Kidney Failure, Chronic
• Small for Gestational Age
• Turner Syndrome

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measure : adverse event		up to 2 years after epiphyseal closure
Secondary	effectiveness measure : difference in target height and final height		up to 2 years after epiphyseal closure
Secondary	effectiveness : difference in height velocity between Baseline and every year		up to 2 years after epiphyseal closure
Secondary	effectiveness measure : difference in height SDS for CA between baseline and every 6 months		up to 2 years after epiphyseal closure