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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001061-29 | EudraCT Number |
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This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Experimental |
| |
| D | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC126-0083 | Drug | Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (adverse events, local tolerability, physical examination) | 0 to 10 days after third dosing, (day 15-25 after first dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, maximum concentration of IGF-I | after trial product administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Århus C | 8000 | Denmark | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21177789 | Result | Sondergaard E, Klose M, Hansen M, Hansen BS, Andersen M, Feldt-Rasmussen U, Laursen T, Rasmussen MH, Christiansen JS. Pegylated long-acting human growth hormone possesses a promising once-weekly treatment profile, and multiple dosing is well tolerated in adult patients with growth hormone deficiency. J Clin Endocrinol Metab. 2011 Mar;96(3):681-8. doi: 10.1210/jc.2010-1931. Epub 2010 Dec 22. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| NNC126-0083 | Drug | Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks |
|
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| NNC126-0083 | Drug | Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks |
|
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| NNC126-0083 | Drug | Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks |
|
|
| placebo | Drug | Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks |
|
| placebo | Drug | Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks |
|
| placebo | Drug | Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks |
|
| placebo | Drug | Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks |
|
| København Ø |
| 2100 |
| Denmark |
| Novo Nordisk Investigational Site | Odense | 5000 | Denmark |
| 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 |
|---|---|
| C558310 | NNC126-0083 |
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