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Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature

Primary Purpose

Idiopathic Short Stature

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DA-3002
Sponsored by
Dong-A ST Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Short Stature focused on measuring growth hormone

Eligibility Criteria

4 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronological Age ≥ 4
  • Bone Age <11 (for girls) and <13 (for boys)
  • Height <3rd percentile for age
  • normal thyroid function

Exclusion Criteria:

  • endocrine and/or metabolic disorders
  • growth failure caused by other disorders
  • previous use of drugs that could interfere with Growth Hormone treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    DA-3002 Treatment group

    Non-treatment control group

    Arm Description

    1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)

    Height be measured with no treatment

    Outcomes

    Primary Outcome Measures

    Annualized Height Velocity(cm/Year) After 26 Weeks
    Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.

    Secondary Outcome Measures

    Changes in Height Standard Deviation Score After 26 Weeks
    The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height.

    Full Information

    First Posted
    February 6, 2013
    Last Updated
    September 18, 2017
    Sponsor
    Dong-A ST Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01786902
    Brief Title
    Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature
    Official Title
    Open, Multi-Center, Controlled, Randomized Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-3002(Recombinant Humn Growth Hormone)Treatment in Children With Idiopathic Short Stature
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2012 (undefined)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dong-A ST Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Idiopathic Short Stature
    Keywords
    growth hormone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DA-3002 Treatment group
    Arm Type
    Experimental
    Arm Description
    1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
    Arm Title
    Non-treatment control group
    Arm Type
    No Intervention
    Arm Description
    Height be measured with no treatment
    Intervention Type
    Drug
    Intervention Name(s)
    DA-3002
    Other Intervention Name(s)
    Recombinant Human Growth Hormone
    Primary Outcome Measure Information:
    Title
    Annualized Height Velocity(cm/Year) After 26 Weeks
    Description
    Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.
    Time Frame
    26 weeks
    Secondary Outcome Measure Information:
    Title
    Changes in Height Standard Deviation Score After 26 Weeks
    Description
    The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height.
    Time Frame
    26 weeks
    Other Pre-specified Outcome Measures:
    Title
    Changes in Anti-growth Hormone Antibody
    Time Frame
    baseline and 26 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronological Age ≥ 4 Bone Age <11 (for girls) and <13 (for boys) Height <3rd percentile for age normal thyroid function Exclusion Criteria: endocrine and/or metabolic disorders growth failure caused by other disorders previous use of drugs that could interfere with Growth Hormone treatment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hanwook Yoo, MD
    Organizational Affiliation
    Asan Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Byungkyu Suh, MD
    Organizational Affiliation
    Seoul St. Mary's Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Cheolwoo Ko, MD
    Organizational Affiliation
    Kyungpook National University Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Keehyoung Lee, MD
    Organizational Affiliation
    Korea University Anam Hospitial
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Dongkyu Jin, MD
    Organizational Affiliation
    Samsung Medical Center
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Choongho Shin, MD
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Jinsoon Hwang, MD
    Organizational Affiliation
    Aju University Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Hoseong Kim, MD
    Organizational Affiliation
    Severance Children's Hospital Yonsei University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Wooyoung Jeong, MD
    Organizational Affiliation
    Pusan University Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Chanjong Kim, MD
    Organizational Affiliation
    Chonnam National University Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Heonsuk Han, MD
    Organizational Affiliation
    Chungbuk National University Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature

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