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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20200399 | Other Identifier | Center for drug evaluation,NMPA |
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| Name | Class |
|---|---|
| Ascendis Pharma A/S | INDUSTRY |
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This study is conducted in China only. The purpose is to demonstrate the efficacy and safety of once weekly dosing of TransCon hGH, a long-acting growth hormone product, compare to once-daily dosing of human growth hormone (hGH) after 52 weeks of treatment in prepubertal children with growth hormone deficiency (GHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TransCon hGH | Experimental | TransCon hGH will be self-administered or injected by parents once weekly. The dose will be adjusted based on subject's weight. The treatment will continue 52 weeks. |
|
| Daily hGH | Active Comparator | Daily hGH will be self-administered or injected by parents once daily. The dose will be adjusted based on subject's weight. The treatment will continue 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TransCon hGH | Drug | Once weekly subcutaneous injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized height velocity(AHV) at Week 52 | Annualized height velocity at Week 52 for weekly TransCon hGH treatment and the daily hGH treatment groups | 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AHV and the change from baseline over 52 weeks at each visit | AHV and the change from baseline for the TransCon hGH and the daily hGH treatment group over 52 weeks at each visit | 52 Weeks |
| Height SDS and the change from baseline over 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Chen, MD | Contact | +86-02152999605 | lisa.chen@visenpharma.com | |
| xiangling Wang, MD | Contact | xiangling.wang@visenpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoping Luo, MD | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, | Recruiting | Wuhan | Hubei | 430030 | China |
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Eligible subjects will be randomized to 1 of the 2 treatment groups: either weekly TransCon hGH or daily hGH, in a 2:1 ratio
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| daily hGH | Drug | Once daily subcutaneous injection |
|
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Height SDS and the change from baseline for the TransCon hGH and the daily hGH treatment group over 52 weeks
| 52 weeks |
| Serum IGF-1 and IGFBP-3 levels, and IGF-1 SDS, IGFBP-3 SDS, and the change from baseline over 52 weeks at each visit | Serum IGF-1 and IGFBP-3 levels, and IGF-1 SDS, IGFBP-3 SDS, and the change from baseline for the TransCon hGH and the daily hGH treatment group over 52 weeks at each visit | 52 weeks |
| The percentage of participants achieving IGF-1 SDS 0 to +2.0 | The normalization of IGF-1 SDS (percentage of participants achieving IGF-1 SDS 0 to +2.0 over 52 weeks for the TransCon hGH and the daily hGH treatment group | 52 weeks |
| Incidence of Treatment-Emergent Adverse Events | 52 weeks |
| The plasma concentration | pharmacokinetics measure of hGH over 52 weeks in TransCon hGH group | 52 weeks |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| D004700 | Endocrine System Diseases |
| D010900 | Pituitary Diseases |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000723007 | lonapegsomatropin |
| D019382 | Human Growth Hormone |
| D000074584 | WW Domain-Containing Oxidoreductase |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000074583 | Short Chain Dehydrogenase-Reductases |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
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