Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short children born small for gestational age.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-3002 | Experimental | 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). |
|
| Genotropin® | Active Comparator | 1.44 IU (0.48mg)/kg/week of Genotropin is injected for 52 weeks by changing injecting areas(six or seven times per week). |
|
| Non-treatment control group | Other | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-3002 | Drug |
| ||
| Genotropin® |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized height velocity(cm/year) after 52 weeks. | Height velocity calculated with height measured at Baseline and after 52 weeks was converted to annual growth rate. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized height velocity(cm/year) after 26 weeks. | Height velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate. | 26 weeks |
| Changes in height standard deviation score after 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in anti-growth hormone antibody | 52 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34397702 | Derived | Kim SJ, Kim MS, Cho SY, Suh BK, Ko CW, Lee KH, Yoo HW, Shin CH, Hwang JS, Kim HS, Chung WY, Kim CJ, Han HS, Jin DK. Efficacy and safety of the recombinant human growth hormone in short children born small for gestational age: A randomized, multicentre, comparative phase III trial. Medicine (Baltimore). 2021 Jul 30;100(30):e26711. doi: 10.1097/MD.0000000000026711. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| 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 |
| 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 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |