Actively Recruiting

Age: 2Years +
All Genders
ID01604395

An Open, Multi-center, Prospective and Retrospective Observational Study to Evaluate the Long-term Safety and Effectiveness of Growth Hormone Treatment With GHD, TS, CRF, SGA, ISS, and PWS in Children

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

6000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

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

Who Can Participate

Age: 2Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 2 years or older with short stature
  • 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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

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Research Team

Y

YoungHwan Jang

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

Adiposity Rebound Timing in Small for Gestational Age Children Treated With Growth Hormone: Results From LG Growth Study Data.

Ji Hyun Kim, Su Jin Kim, In Hyuk Chung...

https://pubmed.ncbi.nlm.nih.gov/39901524

Growth Prediction Model for Prepubertal Children With Idiopathic Growth Hormone Deficiency: An Analysis of LG Growth Study Data.

Hwal Rim Jeong, Hae Sang Lee, Jin Soon Hwang

https://pubmed.ncbi.nlm.nih.gov/39676465

Long-term effectiveness of growth hormone therapy in children born small for gestational age: An analysis of LG growth study data.

Hae Sang Lee, Change Dae Kum, Jung Gi Rho...

https://pubmed.ncbi.nlm.nih.gov/35472208

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.

Han Hyuk Lim, Yoo Mi Kim, Gyung Min Lee...

https://pubmed.ncbi.nlm.nih.gov/35315601

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.

Won Kyoung Cho, Moon Bae Ahn, Eun Young Kim...

https://pubmed.ncbi.nlm.nih.gov/32419399