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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01813630
First Posted: March 19, 2013
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
  Purpose
A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin®.

Condition Intervention Phase
Turner's Syndrome Drug: DA-3002 Drug: Genotropin® Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Clinical Trial for Assessment of Efficacy and Safety of DA-3002 (Recombinant Human Growth Hormone) in Patients With Turner's Syndrome

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • 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


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

Other Outcome Measures:
  • Changes in anti-growth hormone antibody [ Time Frame: 52 weeks ]

Enrollment: 58
Study Start Date: February 2013
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813630


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
Principal Investigator: Han Wook Yoo, M.D., Ph.D. Asan 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
Principal Investigator: Kee Hyoung Lee, M.D., Ph.D. Korea University Anam Hospital
Principal Investigator: Dong Kyu Jin, M.D.,Ph.D. Seoul 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
  More Information

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01813630     History of Changes
Other Study ID Numbers: DA3002_TS_III
First Submitted: March 15, 2013
First Posted: March 19, 2013
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by Dong-A ST Co., Ltd.:
Turner's Syndrome
Short Stature
Dwarfism

Additional relevant MeSH terms:
Syndrome
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Disease
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female