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
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®.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-3002 | Experimental | 0.14 IU (0.045-0.050mg)/kg/day of DA-3002 is injected for 52 weeks by changing injecting areas |
|
| Genotropin® | Active Comparator | 0.14 IU (0.045-0.050mg)/kg/day of Genotropin is injected for 52 weeks by changing injecting areas |
|
| 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 |
|---|---|---|
| Changes in height standard deviation score after 52 weeks | 52 weeks | |
| Changes in bone maturation(changes in bone ages/changes in chronological age) | 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 |
|---|---|---|
| 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 Hospital | 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34893062 | Derived | Kim J, Kim MS, Suh BK, Ko CW, Lee KH, Yoo HW, Shin CH, Hwang JS, Kim HS, Chung WY, Kim CJ, Han HS, Jin DK. Recombinant growth hormone therapy in children with Turner Syndrome in Korea: a phase III Randomized Trial. BMC Endocr Disord. 2021 Dec 10;21(1):243. doi: 10.1186/s12902-021-00904-5. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014424 | Turner Syndrome |
| D004392 | Dwarfism |
| ID | Term |
|---|---|
| D006059 | Gonadal Dysgenesis |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
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
|
| Changes in IGF-1 |
| 52 weeks |
| Changes in IGFBP-3 | 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 |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D058533 | Sex Chromosome Disorders of Sex Development |
| D052801 | Male Urogenital Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |