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

September 18, 2017 updated by: Dong-A ST Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

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

4 years to 13 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DA-3002 Treatment group
1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
Drug: DA-3002
Other Names:
  • Recombinant Human Growth Hormone
NO_INTERVENTION: Non-treatment control group
Height be measured with no treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Height Standard Deviation Score After 26 Weeks
Time Frame: 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.
26 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Changes in Anti-growth Hormone Antibody
Time Frame: baseline and 26 weeks
baseline and 26 weeks

Collaborators and Investigators

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

Sponsor

Dong-A ST Co., Ltd.

Investigators

  • Principal Investigator: Hanwook Yoo, MD, Asan Medical Center
  • Study Director: Byungkyu Suh, MD, Seoul ST. Mary's Hospital
  • Study Director: Cheolwoo Ko, MD, Kyungpook National University Hospital
  • Study Director: Keehyoung Lee, MD, Korea University Anam Hospitial
  • Study Director: Dongkyu Jin, MD, Samsung Medical Center
  • Study Director: Choongho Shin, MD, Seoul National University Hospital
  • Study Director: Jinsoon Hwang, MD, Aju University Hospital
  • Study Director: Hoseong Kim, MD, Severance Children's Hospital Yonsei University
  • Study Director: Wooyoung Jeong, MD, Pusan University Hospital
  • Study Director: Chanjong Kim, MD, Chonnam National University Hospital
  • Study Director: Heonsuk Han, MD, Chungbuk National University Hospital

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

February 1, 2012

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 7, 2013

First Posted (ESTIMATE)

February 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2017

Last Update Submitted That Met QC Criteria

September 18, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA3002_ISS_III

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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