Efficacy and Safety of DA-3002 in Short Children Borns SGA. (SGA)

October 13, 2019 updated by: Dong-A ST Co., Ltd.

Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Short Children Born Small for Gestational Age.

A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short children born small for gestational age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

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 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronological Age ≥ 4
  • Before the adolescence, Tuner stage I (breast)
  • Height <3rd percentile for age
  • Normal thyroid function

Exclusion Criteria:

  • Growth hormone was administered for 12 months or longer in the past
  • Treated with estrogen or adrenal androgens for 12 months or longer in the past
  • Malignancy, CNS Trauma, Psychiatric Disorder
  • endocrine and/or metabolic disorders
  • growth failure caused by other disorders

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DA-3002
1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week).
Drug: DA-3002
Active Comparator: Genotropin®
1.44 IU (0.48mg)/kg/week of Genotropin is injected for 52 weeks by changing injecting areas(six or seven times per week).
Drug: Genotropin®
Other: Non-treatment control group
After no treatment for 26 weeks, 1.44 IU (0.48mg)/kg/week of DA-3002 is injected for 52 weeks by changing injecting areas(six or seven times per week).
Drug: DA-3002

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized height velocity(cm/year) after 52 weeks.
Time Frame: 52 weeks
Height velocity calculated with height measured at Baseline and after 52 weeks was converted to annual growth rate.
52 weeks

Secondary 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
Changes in height standard deviation score after 52 weeks
Time Frame: 52 weeks
52 weeks
Changes in bone maturation(changes in bone ages/changes in chronological age) after 52 weeks
Time Frame: 52 weeks
52 weeks
Changes in IGF-1 after 52 weeks
Time Frame: 52 weeks
52 weeks
Changes in IGFBP-3 after 52 weeks
Time Frame: 52 weeks
52 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Changes in anti-growth hormone antibody
Time Frame: 52 weeks
52 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: Dong kyu Jin, M.D., Ph.D., Seoul Samsung Medical center.
  • Principal Investigator: Byung Kyu Suh, M.D., Ph.D., Seoul St. Mary's Hospital, The Catholic University of Korea
  • Principal Investigator: Cheol Woo Ko, M.D., Ph.D., Kyungpook National University Hospital
  • Principal Investigator: Kee Hyoung Lee, M.D., Ph.D., Korea University Anam Hospital
  • Principal Investigator: Han Wook Yoo, M.D., Ph.D., Asan Medical Center
  • Principal Investigator: Choong Ho Shin, M.D., Ph.D., Seoul National University Hospital
  • Principal Investigator: Jin Soon Hwang, M.D., Ph.D., Aju University Hospital
  • Principal Investigator: Ho Seong Kim, M.D., Ph.D., Severance Children's Hospital Yonsei University
  • Principal Investigator: Woo Young Jeong, M.D., Ph.D., Pusan University Hospital
  • Principal Investigator: Chang Jong Kim, M.D., Ph.D., Chonnam National University Hospital
  • Principal Investigator: Heon Suk Han, M.D., Ph.D., Chungbuk National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 26, 2016

Primary Completion (Actual)

August 28, 2019

Study Completion (Actual)

August 28, 2019

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Actual)

October 16, 2019

Last Update Submitted That Met QC Criteria

October 13, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • DA3002_SGA_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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