Efficacy and Safety of DA-3002 in Short Children Borns SGA.
Study Details
Study Description
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 |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Annualized height velocity(cm/year) after 52 weeks. [52 weeks]
Height velocity calculated with height measured at Baseline and after 52 weeks was converted to annual growth rate.
Secondary Outcome Measures
- Annualized height velocity(cm/year) after 26 weeks. [26 weeks]
Height velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.
- Changes in height standard deviation score after 52 weeks [52 weeks]
- Changes in bone maturation(changes in bone ages/changes in chronological age) after 52 weeks [52 weeks]
- Changes in IGF-1 after 52 weeks [52 weeks]
- Changes in IGFBP-3 after 52 weeks [52 weeks]
Other Outcome Measures
- Changes in anti-growth hormone antibody [52 weeks]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DA3002_SGA_III