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Recruiting NCT04798690

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

— Observational Growth Hormone Deficiency Idiopathic Short Stature Turner Syndrome Small for Gestational Age

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Growth Hormone Deficiency, Idiopathic Short Stature, Turner Syndrome, Small for Gestational Age. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Primary outcome measures

  • Long term safety assessed through the adverse events [Time frame: Up to 2 years after epiphyseal closure]
Secondary outcome measures (7)
  • Change of annualized height velocity [Time frame: Up to 2 years after epiphyseal closure]
  • The difference between target height and final height [Time frame: Up to 2 years after epiphyseal closure]
  • Changes in Height SDS [Time frame: Up to 2 years after epiphyseal closure]
  • Changes in skeletal maturity [Time frame: Up to 2 years after epiphyseal closure]
  • Changes in IGF-1 [Time frame: Up to 2 years after epiphyseal closure]
  • Changes in IGFBP-3 [Time frame: Up to 2 years after epiphyseal closure]
  • Changes in BMI SDS [Time frame: Up to 2 years after epiphyseal closure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Yonsei University Health System, Severance Hospital — Seoul

Identifiers

NCT: NCT04798690 · DA3002_SS_OS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗