Skip to main content
OpenTrials
Recruiting

NCT Number: NCT01604395

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Chromosome Disorders Chronic Disease Chronic Renal Failure Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Disorders of Sex Development Dwarfism Dwarfism, Pituitary Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Gonadal Dysgenesis Heart Defects, Congenital Heart Diseases Hypopituitarism Hypothalamic Diseases Idiopathic Short Stature Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Musculoskeletal Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Renal Insufficiency Renal Insufficiency, Chronic Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Small for Gestational Age Turner Syndrome Urogenital Abnormalities Urogenital Diseases Urologic Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

CH Shin, M.D.

CONTACT

CH Shin, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Safety measure : adverse event

    Time frame: up to 2 years after epiphyseal closure

Secondary outcomes

  1. effectiveness measure : difference in target height and final height

    Time frame: up to 2 years after epiphyseal closure

  2. effectiveness : difference in height velocity between Baseline and every year

    Time frame: up to 2 years after epiphyseal closure

  3. effectiveness measure : difference in height SDS for CA between baseline and every 6 months

    Time frame: up to 2 years after epiphyseal closure

Study contacts

Contact information is provided by the study sponsor or research team.

YoungHwan Jang

CONTACT

[email protected]

82-2-6924-3158

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

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

Acronym: LGS

Important dates

Study start
2012
Primary completion
2032
Study completion
2032
First posted
May 23, 2012
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.