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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Dong-A ST Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01813630
First received: March 15, 2013
Last updated: August 12, 2013
Last verified: August 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:
  • A comparison of annualized height velocity between the DA-3002 treated group and the Genotropin® treated group after 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A difference of Height Standard Deviation Score between the DA treated group and the Genotropin® treated group after 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The change of antibodies to growth hormone [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 58
Study Start Date: February 2013
Estimated Primary Completion Date: June 2016 (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

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813630

Contacts
Contact: Dong Kyu Jin, M.D., Ph.D. 82-2-1599-3114

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jin Dong Kyu, M.D., Ph.D.    82-2-1599-3114      
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
  More Information

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01813630     History of Changes
Other Study ID Numbers: DA3002_TS_III (Version 1.2)
Study First Received: March 15, 2013
Last Updated: August 12, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Syndrome
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

ClinicalTrials.gov processed this record on September 18, 2014