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

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04798690
Collaborator
(none)
2,500
Enrollment
1
Location
129.7
Anticipated Duration (Months)
19.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    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
    Actual Study Start Date :
    Feb 8, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2031
    Anticipated Study Completion Date :
    Dec 1, 2031

    Arms and Interventions

    Arm Intervention/Treatment
    Growth hormone

    Growtropin®-II

    Outcome Measures

    Primary Outcome Measures

    1. Long term safety assessed through the adverse events [Up to 2 years after epiphyseal closure]

      Number of occurrence of treatment-related adverse events

    Secondary Outcome Measures

    1. Change of annualized height velocity [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 [Up to 2 years after epiphyseal closure]

      To assess the difference in target height and final height

    3. Changes in Height SDS [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 [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 [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 [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 [Up to 2 years after epiphyseal closure]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei University Health System, Severance Hospital Seoul Seodaemun-gu Korea, Republic of 03722

    Sponsors and Collaborators

    • Dong-A ST Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong-A ST Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04798690
    Other Study ID Numbers:
    • DA3002_SS_OS
    First Posted:
    Mar 15, 2021
    Last Update Posted:
    Mar 15, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dwarfism
    Turner Syndrome
    Gonadal Dysgenesis

    Study Results

    No Results Posted as of Mar 15, 2021