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The purpose of this study is to assess the safety, tolerability and Pharmacokinetic/ Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and one dose on every other week (EOW) regime administered for a period of 24 weeks initial study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Once weekly HM10560A |
|
| Cohort 2 | Experimental | Once weekly HM10560A |
|
| Cohort 3 | Experimental | Once weekly HM10560A |
|
| Cohort 4 | Experimental | Biweekly HM10560A |
|
| Cohort 5 | Active Comparator | Once daily Genotropin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM10560A | Drug | Once weekly HM10560A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of IGF-I levels in function of time, and dose strengths | The results from each month minus baseline | baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months |
| Measure | Description | Time Frame |
|---|---|---|
| IGF-I SDS; changes to baseline in IGF-I SDS | The results from each month minus baseline | baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanmi Pharmaceutical | Budapest | Hungary |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal 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 |
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| Genotropin | Drug | Once daily Genotropin |
|
|
| 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 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |