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ID01604395

Study of Long-term Safety and Effectiveness of Growth Hormone Treatment in Children with Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age, and Idiopathic Short Stature

Led by LG Chem · Updated on 2021-02-21

6000

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the long-term safety and effectiveness of growth hormone treatments called Eutropin Inj. and Eutropin Plus Inj. in children with conditions that affect growth, including Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age, and Idiopathic Short Stature. This observational study aims to understand how these treatments work over time and monitor any side effects. The study observes children who are receiving growth hormone therapy without assigning specific treatments or placebo groups. The research collects data over an extended period, including up to two years after the growth plates epiphyseal have closed. This allows researchers to assess the safety by tracking adverse events and evaluate effectiveness by measuring changes in height and growth velocity. Participants will be monitored through regular assessments that measure height differences compared to target heights and baseline measurements. These include evaluations every six months and annually, focusing on height standard deviation scores and growth speed. Safety is closely watched by recording any adverse events during the study period. The total involvement lasts up to two years after the participants growth plates close, ensuring long-term observations of treatment outcomes.

CONDITIONS

Brief Title

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

Research Team

Y

YoungHwan Jang

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