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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01604395
Other study ID # LG-HGOS001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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