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The purpose of this study is to learn about the long-term safety and effects of Ngenla. Ngenla is approved for treatment of GHD (Growth hormone deficiency) without epiphyseal closure under daily medical practice.
Registration criteria of this study are the patients who:
All patients in this study will receive Ngenla according to the prescriptions. We will examine their experiences for a long time. This will help us to determine the safety and effects of Ngelna for long-term use.
Patients will be followed up from the date of first Ngenla treatment until November 30, 2027.
This is a multi-center cohort study in patients with GHD without epiphyseal closure receiving NGENLA® Subcutaneous Injection. The investigators complete the case report form (CRF) based on the information extracted from the medical record created in daily medical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGENLA (Somatrogon) | Patients with GHD without epiphyseal closure who received NGENLA (Somatrogon) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGENLA (Somatrogon) | Drug | Dosage, Frequency: Refer to the latest package insert. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients reporting Adverse Events (AEs) | up to 5 years | |
| Incidence of Glucose metabolism disorders per exposure period | up to 5 years | |
| Incidence of Neoplasm per exposure period | up to 5 years | |
| Annual growth rate (cm/year) | up to 5 years | |
| Growth rate standard deviation score (SDS) for chronological age | up to 5 years | |
| Change in height SDS for chronological age and time-course of height SDS for chronological age | up to 5 years | |
| Proportion of reported Adverse Events | up to 5 years |
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Patients who satisfy all of the registration criteria are subject to this study.
Registration criteria
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Patients with GHD without epiphyseal closure who received NGENLA
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000723339 | somatrogon |
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| 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 |