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| Name | Class |
|---|---|
| Huazhong University of Science and Technology | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Capital Medical University | OTHER |
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The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegylated Somatropin | Drug | 0.1 mg/kg/wk once a week for 25 weeks |
| |
| pegylated Somatropin | Drug | 0.2 mg/kg/wk once a week for 25 weeks |
| |
| Jintropin AQ | Drug | 0.25 mg/kg/wk, once a day for 25 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth velocity | 25 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| height standard deviation score for chronological age (Ht SDSCA) | 25 weeks | |
| IGF-1 | 25 weeks | |
| IGFBP3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoping Luo, Doctor | Tongji Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28566441 | Result | Luo X, Hou L, Liang L, Dong G, Shen S, Zhao Z, Gong CX, Li Y, Du ML, Su Z, Du H, Yan C. Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies. Eur J Endocrinol. 2017 Aug;177(2):195-205. doi: 10.1530/EJE-16-0905. Epub 2017 May 31. |
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Children's Hospital of Fudan University |
| OTHER |
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| 25 weeks |
| D001849 |
| Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |