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The purpose of the study is to evaluate the safety and effectiveness of ALTU-238 in the treatment of children with growth hormone deficiency who have not yet reached puberty who lack the normal ability to make growth hormone themselves. This study will also test if ALTU-238 works as a weekly treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ALTU-238 |
|
| 2 | Experimental | ALTU-238 |
|
| 3 | Experimental | ALTU-238 |
|
| 4 | Active Comparator | Nutropin AQ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatropin | Drug | ALTU-238 0.3 mg/kg daily |
| |
| Somatropin |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in annualized height velocity from pre-treatment to the first 26 weeks of treatment | 26 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth Attie, Medical Monitor | Contact | 781-373-6481 | kattie@altus.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Recruiting | Little Rock | Arkansas | 72202 | United States |
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| Drug |
ALTU-238 0.6 mg/kg daily |
|
| Somatropin | Drug | ALTU-238 0.9 mg/kg daily |
|
| Somatropin | Drug | Nutropin AQ 0.043 mg/kg daily |
|
| Nemours Children's Clinic | Recruiting | Orlando | Florida | 32806 | United States |
|
| Baystate Medical Centre | Recruiting | Springfield | Massachusetts | 01199 | United States |
|
| UMass Memorial Medical Center | Recruiting | Worcester | Massachusetts | 01655 | United States |
|
| Children's Mercy Hospital | Recruiting | Kansas City | Missouri | 64108 | United States |
|
| Morristown Memorial Hospital | Recruiting | Morristown | New Jersey | 07962 | United States |
|
| Schneider Children's Hospital | Recruiting | New Hyde Park | New York | 11040 | United States |
|
| Children's Hospital Medical Centre | Recruiting | Cincinnati | Ohio | 45229 | United States |
|
| Cook Children's Hospital | Recruiting | Fort Worth | Texas | 76104 | United States |
|
| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
|
| Swedish Medical Center | Recruiting | Seattle | Washington | 98122 | United States |
|
| 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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