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The purpose of this study is to evaluate the efficacy and safety of weekly GenSci004 compared with daily Genotropin in treatment-naive children with growth failure due to GHD.
The purpose of this Phase 3 study is to evaluate the efficacy, safety, and tolerability of weekly GenSci004 compared to daily Genotropin over 52 weeks in prepubertal treatment-naïve children with growth failure due to GHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GenSci004 | Experimental |
| |
| Genotropin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GenSci004 | Drug | GenSci004 is a pegylated rhGH (PEG rhGH) (i.e., PEG-somatropin) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups | Measured in centimeter per year (cm/year) | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Height Velocity (AHV) for GenSci004 and Genotropin groups | Measured in centimeter per year (cm/year) | 104 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Duan | Contact | +86-431-85195060 | info@gensci-china.com |
| Name | Affiliation | Role |
|---|---|---|
| Bradley Miller | University of Minnesota | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cook Childrens | Fort Worth | Texas | 76104 | United States |
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| Genotropin |
| Drug |
Genotropin |
|
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| 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 |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| 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 |
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