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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Diagnosed with Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age, or Idiopathic Short Stature
Written informed consent from the participant, parent, or legal guardian
You will not qualify if you...
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 2 years after epiphyseal closure
Participants who have received growth hormone treatment are observed for safety and effectiveness over time.
Visits every 6 months and annually for assessments
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Predicting First-Year Growth in Response to Growth Hormone Treatment in Prepubertal Korean Children with Idiopathic Growth Hormone Deficiency: Analysis of Data from the LG Growth Study Database.
Growth Responses During 3 Years of Growth Hormone Treatment in Children and Adolescents With Growth Hormone Deficiency: Comparison Between Idiopathic, Organic and Isolated Growth Hormone Deficiency, and Multiple Pituitary Hormone Deficiency.