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NCT Number: NCT04798690

Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature

This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.

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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 Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities 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 Male Urogenital Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Small for Gestational Age Turner Syndrome Urogenital Abnormalities Urogenital Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei University Health System, Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

Location status: Recruiting

Location contact

Ho Seong Kim, M.D., Ph.D

CONTACT

[email protected]

+82-2-2228-2069

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children with short stature by growth hormone deficiency(GHD) or idiopathic short stature (ISS) or turner's syndrome(TS) or small for gestational age(SGA)
  • Children who has official height record at least 6 months prior

Exclusion criteria

  • Children with Epiphyseal closure

Treatment and study plan

Primary outcomes

  1. Long term safety assessed through the adverse events

    Time frame: Up to 2 years after epiphyseal closure

    Number of occurrence of treatment-related adverse events

Secondary outcomes

  1. Change of annualized height velocity

    Time frame: Up to 2 years after epiphyseal closure

    To assess the difference in change of annualized height velocity between baseline and every 6 months

  2. The difference between target height and final height

    Time frame: Up to 2 years after epiphyseal closure

    To assess the difference in target height and final height

  3. Changes in Height SDS

    Time frame: Up to 2 years after epiphyseal closure

    To assess the changes in Height SDS between baseline and every 6 months

  4. Changes in skeletal maturity

    Time frame: Up to 2 years after epiphyseal closure

    To assess the changes in skeletal maturity between baseline and every 6 months

  5. Changes in IGF-1

    Time frame: Up to 2 years after epiphyseal closure

    To assess the changes in IGF-1 between baseline and every 6 months

  6. Changes in IGFBP-3

    Time frame: Up to 2 years after epiphyseal closure

    To assess the changes in IGFBP-3 between baseline and every 6 months

  7. Changes in BMI SDS

    Time frame: Up to 2 years after epiphyseal closure

    To assess the changes in BMI SDS between baseline and every 6 months

Study contacts

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

Sung

CONTACT

[email protected]

+82-2-920-8369

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

Open, Multi-center, Non-interventional, Prospective/ Retrospective Observational Study on Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature

Important dates

Study start
2021
Primary completion
2035
Study completion
2035
First posted
Mar 15, 2021
Registry last updated
Jul 21, 2026

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.

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