A Clinical Study to Assess the Efficacy and Safety of DA-3002

July 24, 2018 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 Patients With Turner's Syndrome

A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

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

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with Turner's Syndrome through chromosome analysis
  • The chronological age: 2≤AGE≤12
  • The yearly growth rate should be less than 6cm; the bone age should be equal or less than 12; the height ≤ 10th percentile for the heights of their agemates
  • Before the adolescence, Tuner stage I (breast)
  • 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

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
0.14 IU (0.045-0.050mg)/kg/day of DA-3002 is injected for 52 weeks by changing injecting areas
Drug: DA-3002
Active Comparator: Genotropin®
0.14 IU (0.045-0.050mg)/kg/day of Genotropin is injected for 52 weeks by changing injecting areas
Drug: Genotropin®

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
Time Frame
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)
Time Frame: 52 weeks
52 weeks
Changes in IGF-1
Time Frame: 52 weeks
52 weeks
Changes in IGFBP-3
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: 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
  • Principal Investigator: Dong Kyu Jin, M.D.,Ph.D., Seoul Medical Center

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 1, 2013

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

March 15, 2013

First Submitted That Met QC Criteria

March 18, 2013

First Posted (Estimate)

March 19, 2013

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA3002_TS_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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