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

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ClinicalTrials.gov Identifier: NCT02770157
Recruitment Status : Active, not recruiting
First Posted : May 12, 2016
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Infant, Small for Gestational Age Drug: DA-3002 Drug: Genotropin® Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
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 Short Children Born Small for Gestational Age.
Actual Study Start Date : February 26, 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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®
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



Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Changes in height standard deviation score after 52 weeks [ Time Frame: 52 weeks ]
  3. Changes in bone maturation(changes in bone ages/changes in chronological age) after 52 weeks [ Time Frame: 52 weeks ]
  4. Changes in IGF-1 after 52 weeks [ Time Frame: 52 weeks ]
  5. Changes in IGFBP-3 after 52 weeks [ Time Frame: 52 weeks ]

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


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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02770157


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
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
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

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02770157     History of Changes
Other Study ID Numbers: DA3002_SGA_III
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018