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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004975-37 | EudraCT Number |
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The primary objective of this study is to evaluate the clinical effect of TV-1106.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| recombinant human growth hormone | Active Comparator | Daily subcutaneous dose |
|
| TV-1106 | Experimental | Titration dose levels of TV-1106 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TV-1106 | Drug |
| ||
| Recombinant human growth hormone |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin-like growth factor I (IGF-I) concentration change from baseline | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS | Baseline to Week 12 | |
| Safety Parameters | The safety of TV-1106 will be assessed throughout the study by evaluating adverse events,concomitant medication usage, physical examinations including urinalysis and body weight, vital sign measurements, clinical laboratory test results and hormone levels, electrocardiograms (ECGs), and immunogenicity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 10564 | Portland | Oregon | 97239 | United States | ||
| Teva Investigational Site 54052 |
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Subcutaneous once daily |
|
| 78 weeks |
| Hradec Králové |
| 500 05 |
| Czechia |
| Teva Investigational Site 54051 | Olomouc | 775 20 | Czechia |
| Teva Investigational Site 32239 | Dresden | 01307 | Germany |
| Teva Investigational Site 32238 | Munich | 80336 | Germany |
| Teva Investigational Site 32237 | Munich | 80804 | Germany |
| Teva Investigational Site 63044 | Athens | 10676 | Greece |
| Teva Investigational Site 63045 | Athens | 11527 | Greece |
| Teva Investigational Site 51056 | Budapest | 1062 | Hungary |
| Teva Investigational Site 51055 | Budapest | 1088 | Hungary |
| Teva Investigational Site 51060 | Debrecen | 4012 | Hungary |
| Teva Investigational Site 51061 | Győr | H-9023 | Hungary |
| Teva Investigational Site 51059 | Pécs | 7624 | Hungary |
| Teva Investigational Site 51057 | Szeged | H-6720 | Hungary |
| Teva Investigational Site 51058 | Szolnok | 5000 | Hungary |
| Teva Investigational Site 80033 | Jerusalem | 91120 | Israel |
| Teva Investigational Site 80032 | Petah Tikva | 49100 | Israel |
| Teva Investigational Site 80034 | Tel Aviv | 78278 | Israel |
| Teva Investigational Site 61029 | Belgrade | 11 000 | Serbia |
| Teva Investigational Site 62017 | Bratislava | 826 06 | Slovakia |
| Teva Investigational Site 62022 | Bratislava | 833 05 | Slovakia |
| Teva Investigational Site 62016 | Ľubochňa | 034 91 | Slovakia |
| Teva Investigational Site 64016 | Ljubljana | 1525 | Slovenia |
| 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 |
|---|---|
| C000629490 | albusomatropin |
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| 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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