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The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients on SKYTROFA (Lonapegsomatropin)Treatment | SKYTROFA (Lonapegsomatropin) administered once-weekly by subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Drug | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of neoplasms (benign, malignant and unspecified) | 5 years | |
| Occurrence of type 2 diabetes mellitus | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of renal, hepatic, immunologic and neurologic adverse events | 5 years | |
| Occurrence of medication errors in patients treated with lonapegsomatropin | Frequency and type of medication errors as reported by treating physician |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from centres in Europe and the USA will be eligible for enrollment into the study.
Patients may be enrolled in the study if they are on treatment with lonapegsomatropin. The decision to treat the patient with lonapegsomatropin will be made prior to and independently of the decision to invite the patient to enroll into the study. Both patients naïve to GH treatment and patients previously treated with GH therapy will be eligible for enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah Bowlby | Contact | +1 844-442-7236 | SkyPASS_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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| 5 years |
| Insulin-like Growth Factor-1 (IGF-1) response to lonapegsomatropin therapy | IGF-1 level (ng/mL) | 5 years |
| Insulin-like Growth Factor-1 (IGF-1) response to lonapegsomatropin therapy | IGF-1 Standard Deviation Score (SDS) | 5 years |
| Compare the occurrence of neoplasms (benign, malignant and unspecified) in patients treated with lonapegsomatropin with historical data from literature | 5 years |
| Compare the occurrence of type 2 diabetes mellitus in patients treated with lonapegsomatropin with historical data from literature | 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 |
| D005183 | Failure to Thrive |
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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