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

April 11, 2023 updated by: Dong-A ST Co., Ltd.

Open, Multi-center, Non-interventional, Prospective/ Retrospective Observational Study on 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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Seodaemun-gu
      • Seoul, Seodaemun-gu, Korea, Republic of, 03722
        • Recruiting
        • Yonsei University Health system, Severance Hospital
        • Contact:
          • Ho Seong Kim, M.D., Ph.D
          • Phone Number: +82-2-2228-2069
          • Email: kimho@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Short stature by GHD or ISS or TS or SGA

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Growth hormone
Growtropin®-II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 2 years after epiphyseal closure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 2 years after epiphyseal closure
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
Up to 2 years after epiphyseal closure
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
Up to 2 years after epiphyseal closure
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
Up to 2 years after epiphyseal closure
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
Up to 2 years after epiphyseal closure
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
Up to 2 years after epiphyseal closure
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
Up to 2 years after epiphyseal closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2021

Primary Completion (Anticipated)

December 1, 2031

Study Completion (Anticipated)

December 1, 2031

Study Registration Dates

First Submitted

February 17, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA3002_SS_OS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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