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The goal of this study is to genrate evidence on long-term effectiveness and safety of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency under routine clinical care
Patients will be treated according to routine clinical practice, and no additional visits, examinations or tests will be required beyond those performed as part of routine clinical practice except for COAs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients on SKYTROFA Treatment | Patients on SKYTROFA Treatment managed in USA with appropriate written Informed Consent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin) | Incidence of Adverse Events and Serious Adverse Events | 5 years |
| Assess the effectiveness of patients treated with SKYTROFA (Lonapegsomatropin) | Near adult height (cm) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assess clinical outcome assessments (COAs) | Change in Quality of Life in Short Stature Youth (QoLISSY) scores from baseline through End of Study (QOLISSY scores range on a scale of 0 to 100 with higher scores representing better quality of life. (For both child and parent version)) | 5 years |
| Assess clinical outcome assessments (COAs) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients being treated with SKYTROFA who are associated to selected endocrinology or pediatric clinics across USA.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah Bowlby | Contact | +1 844-442-7236 | Skybright_contact@ascendispharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Ascendis Pharma A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascendis Investigational Site | Recruiting | Phoenix | Arizona | 85054 | United States | |
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Change in Treatment Satisfaction Questionnaire for Medicine (TSQM-9) scores from baseline through End of Study (The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain) |
| 5 years |
| Ascendis Investigational Site |
| Recruiting |
| Orange |
| California |
| 92868 |
| United States |
| Ascendis Investigational Site | Recruiting | Sacramento | California | 95821 | United States |
| Ascendis Investigational Site | Recruiting | San Francisco | California | 94143 | United States |
| Ascendis Pharma Investigational Site | Recruiting | Centennial | Colorado | 80112 | United States |
| Ascendis Investigational Site | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| Ascendis Investigational Site | Recruiting | Orlando | Florida | 32806 | United States |
| Ascendis Investigational Site | Recruiting | Orlando | Florida | 32827 | United States |
| Ascendis Investigational Site | Recruiting | Tampa | Florida | 33612 | United States |
| Ascendis Investigational Site | Recruiting | Sandy Springs | Georgia | 30350 | United States |
| Ascendis Investigational Site | Recruiting | Boise | Idaho | 83712 | United States |
| Ascendis Investigational Site | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Ascendis Investigational Site | Recruiting | Iowa City | Iowa | 52242 | United States |
| Ascendis Investigational Site | Recruiting | Louisville | Kentucky | 40202 | United States |
| Ascendis Investigational Site | Recruiting | Minneapolis | Minnesota | 55455 | United States |
| Ascendis Investigational Site | Recruiting | Las Vegas | Nevada | 89113 | United States |
| Ascendis Investigational Site | Recruiting | Lebanon | New Hampshire | 03756 | United States |
| Ascendis Investigational Site | Recruiting | Manchester | New Hampshire | 03104 | United States |
| Ascendis Investigational Site | Recruiting | Morristown | New Jersey | 07960 | United States |
| Ascendis Investigational Site | Recruiting | New Hyde Park | New York | 11042 | United States |
| Ascendis Investigational Site | Recruiting | Cincinnati | Ohio | 45229 | United States |
| Ascendis Investigational Site | Recruiting | Portland | Oregon | 97239 | United States |
| Ascendis Investigational Site | Recruiting | Columbia | South Carolina | 29203 | United States |
| Ascendis Investigational Site | Recruiting | Dallas | Texas | 75390 | United States |
| Ascendis Investigational Site | Recruiting | El Paso | Texas | 79907 | United States |
| Ascendis Investigational Site | Recruiting | Norfolk | Virginia | 23507 | United States |
| Ascendis Investigational Site | Recruiting | Seattle | Washington | 98105 | 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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