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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01604395
Acronym
LGS
Enrollment
6000
Registered
2012-05-23
Start date
2012-01-31
Completion date
2032-12-31
Last updated
2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

GHD, TS, CRF, SGA, ISS, PWS

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).

Interventions

None listed

Sponsors

LG Chem
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Safety measure : adverse eventup to 2 years after epiphyseal closure

Secondary

MeasureTime frame
effectiveness measure : difference in target height and final heightup to 2 years after epiphyseal closure
effectiveness : difference in height velocity between Baseline and every yearup to 2 years after epiphyseal closure
effectiveness measure : difference in height SDS for CA between baseline and every 6 monthsup to 2 years after epiphyseal closure

Countries

South Korea

Contacts

Primary ContactYoungHwan Jang
younghj@lgls.com82-2-6924-3158

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026